Surgical stapler with removable power pack

ABSTRACT

A surgical fastener applier having a housing containing a compartment therein, an elongated member extending distally from the housing and first and second jaws. A firing mechanism is positioned within the housing movable to a second position to effect firing of fasteners. A power pack is removably loadable into the compartment, the power pack having one or both of a) a first motor and a first engagement member removably engageable with the firing mechanism when the power pack is loaded into the compartment to effect movement of the firing mechanism; and b) a second motor and a second engagement member removably engageable with an articulating mechanism in the housing of the surgical fastener applier to effect movement of an articulation mechanism to effect articulation. One or both of a firing position and an articulation position are tracked during the surgical procedure. Sensors are provided to detect select parameters and instrument functions.

This application claims priority from provisional application Ser. No.62/962,388, filed Jan. 17, 2020 and, from provisional application Ser.No. 62/876,586, filed Jul. 19, 2019. The entire contents of each ofthese applications are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This application relates to surgical staplers and removable power packsloadable into the surgical staplers to effect firing of the staples.

2. Background

Surgical staplers are used in various medical applications where adevice is needed to join and dissect anatomical tissue. However, thereare drawbacks and costs associated with use of surgical staplers.Currently staplers are either fully disposable, reusable or partiallyreusable. Due to contamination during the surgical procedure, e.g.,exposure to the patient's body fluids, the staplers are required to besterilized after use, a time consuming and expensive process, withpossible risks of infection if not properly sterilized as contaminantsadhered to the surgical stapler from a previous use could be transferredto another patient. To avoid the risks of resterilization, some surgicalstaplers are disposed after use in the surgical procedure. Thesestaplers can be reloaded to fire multiple cartridges of staples, butafter the procedure, the staplers are discarded. However, the practiceof using single use disposable surgical staplers is costly.

In certain procedures, high forces are required to fire the staplesthrough tissue into contact with the anvil for formation. This iscompounded when multiple rows of staples are fired either simultaneouslyor sequentially from the stapler. Therefore, powered staplers have beenintroduced to reduce the force requirements of the user. Such poweredstaplers have motor driven mechanisms (assemblies) to advance componentswithin the stapler to fire the staples from the cartridge throughtissue. Such powered staplers, if reusable, are subject to the sameaforementioned costs and risk of resterilization. However they sufferfrom additional drawbacks since the sterilization process and/or heat orchemicals used in the sterilization process can damage the electroniccomponents of the drive assemblies, which may shorten the lifespan ofthe surgical stapler or adversely affect its function if resterilizationcompromises the function of the motor or drive assembly. If the stapleris disposable, the stapler becomes more costly since the electroniccomponents, which add to the cost of the stapler, are also discardedwith the stapler.

It would be advantageous to provide a cost effective, efficient, simpleto use and advanced assemblies for powering surgical instruments whichovercome the drawbacks of manual actuation without suffering from thedisadvantages of current power driven staplers.

Further, it would be advantageous to provide such surgical instrumentswhich include systems to evaluate various parameters and functionalitiesto improve operation of the instruments and improve the surgicalprocedures and outcomes.

SUMMARY

The present invention overcomes the deficiencies and disadvantages ofthe prior art. The present invention advantageously provides surgicalstaplers that overcome the drawbacks discussed above by having a fullyenclosed and removable power pack. The surgical staplers according tothe present disclosure may be used multiple times without the need tosterilize the power pack between uses because the power pack is fullyenclosed and sealed by the surgical stapler handle assembly or housing,thereby preventing contact between the power pack and the patient and/orpatient's bodily fluids or the like. Thus, the surgical staplers of thepresent disclosure advantageously reduce the time, resources and/orcosts for preparing the surgical stapler for its next use. The presentdisclosure also provides power packs that are cost effective, efficientand easily loadable into surgical staplers where they engage structurein the housing to effect varied functions of the stapler.

In accordance with one aspect of the present invention, a power packremovably loadable into a compartment of a surgical fastener applier isprovided. The power pack has a) a first motor and b) a first drivemechanism having a first engagement member, the first drive mechanismoperably connected to the motor and the first engagement memberremovably engageable with a firing mechanism of the surgical fastenerapplier when the power pack is loaded into the compartment to effectmovement of the firing mechanism from a first position to the secondposition. A rotatable screw is rotatable by the motor to effect linearmovement of the first engagement member and an encoder is positionedwithin the power pack to detect movement of the rotatable screw todetermine a firing position of the firing mechanism.

In some embodiments, the encoder is mounted to the rotatable screw todetect a rotational position of the screw to determine the axialposition of the first engagement member which in turn detects the axialposition of the firing mechanism of the surgical stapler, the encoderrotatable with rotation of the rotatable screw and rotatable relative toa code wheel fixedly mounted within the power pack.

In other embodiments, the encoder is connected to the first drivemechanism and moves linearly with linear movement of the first drivemechanism to detect a linear position of the first drive mechanism tothereby detect a position of the firing mechanism. The encoder can bemounted to a collar of the first drive mechanism, the collar including aregion forming the first engagement member.

In some embodiments, the power pack includes a second motor, a secondrotatable screw operatively connected to and rotatable by the secondmotor and a second drive mechanism operatively connected to the secondrotatable screw and having a second engagement member removablyengageable with an articulating mechanism in the housing of the surgicalfastener applier to effect movement of the articulation mechanism toeffect articulation of first and second jaws of the surgical staplerfrom a linear position to an angled position. A second encoder ispositioned within the power pack to detect movement of the secondrotatable screw to determine an articulation position of thearticulation mechanism.

In accordance with another aspect of the present invention, a surgicalfastener applier is provided comprising a housing containing acompartment therein, an elongated member extending distally from thehousing, and a first jaw and a second jaw at a distal portion of theelongated member, at least the first jaw movable with respect to thesecond jaw to clamp tissue between the first and second jaws. A firingmechanism is positioned within the housing, the firing mechanism movablebetween a first position and a second position, wherein movement to thesecond position effects firing of fasteners into the tissue clampedbetween the first and second jaws. A power pack is removably loadableinto the compartment, the power pack having a) a first motor and a firstengagement member removably engageable with the firing mechanism whenthe power pack is loaded into the compartment to effect movement of thefiring mechanism from the first position to the second position; and b)a second motor and a second engagement member removably engageable withan articulating mechanism in the housing of the surgical fastenerapplier to effect movement of an articulation mechanism to effectarticulation of the first and second jaws from a linear position to aposition angled with respect to a longitudinal axis of the elongatedmember. A firing position is determined based on a first motor count ofthe first motor and an articulation position is determined based on asecond motor count of the second motor.

In some embodiments, an encoder communicates the motor counts to amicroprocessor within the power pack for adjustment of a motor speed. Insome embodiments, a predetermined time for completion of a firing strokeof the firing mechanism is preset. In some embodiments, if an amperageof the first motor increases above a predetermined threshold, a speed ofthe motor is slowed and the present time is adjusted accordingly.

In accordance with another aspect of the present invention, a power packremovably loadable into a compartment of a surgical fastener applier isprovided. The power pack has a first motor and a first engagement memberremovably engageable with a firing mechanism within the housing of thesurgical fastener applier when the power pack is loaded into thecompartment, the first engagement member movable axially in response torotation of a first screw operatively connected to the first motor. Atleast one thrust bearing limits axial movement of the first screw.Linear movement of the first engagement member effects movement of thefiring mechanism from the first position to the second position. A firstload cell is engageable by the bearing to measure a force during firing.

In some embodiments, the power pack includes a second motor and a secondengagement member removably engageable with an articulation mechanismwithin the housing when the power pack is loaded into the compartment,the second engagement member movable axially in response to rotation ofa second screw operatively connected to the second motor, wherein linearmovement of the second engagement member effects movement of thearticulation mechanism to effect articulation of the first and secondjaws and at least one bearing limits axial movement of the second screw.A second load cell is engageable by the bearing to measure anarticulation force.

In accordance with another aspect of the present invention, a surgicalfastener applier is provided comprising:

-   -   a housing containing a compartment therein, the compartment        having an openable cover to provide access to the compartment        for removably loading a power pack having a motor;    -   an elongated member extending distally from the housing;    -   a first jaw and a second jaw adjacent a distal portion of the        elongated member, at least the first jaw movable with respect to        the second jaw to clamp tissue between the first and second        jaws; and    -   a fastener firing mechanism positioned within the housing, the        firing mechanism movable by the motor of the power pack loaded        into the compartment, the firing mechanism movable between a        first position and a second position, wherein in the second        position, the firing mechanism effects firing of fasteners into        the tissue clamped between the first and second jaws;    -   wherein the motor of the power pack received in the compartment        is not actuable unless the cover is closed.

In some embodiments, the cover includes a member movable into contactwith an activation switch in the power pack when the cover is closed. Insome embodiments, the power pack has a printed circuit board incommunication with the switch.

In accordance with another aspect of the present invention, a surgicalfastener applier is provided comprising:

-   -   a housing containing a compartment therein, the compartment        having an openable cover to provide access to the compartment        for removably loading a power pack having a motor;    -   an elongated member extending distally from the housing;    -   a first jaw and a second jaw adjacent a distal portion of the        elongated member, at least the first jaw movable with respect to        the second jaw to clamp tissue between the first and second        jaws;    -   a fastener firing mechanism positioned within the housing, the        firing mechanism movable by the motor of the power pack loaded        into the compartment, the firing mechanism movable between a        first position and a second position, wherein in the second        position, the firing mechanism effects firing of fasteners into        the tissue clamped between the first and second jaws; and    -   a power pack having an reader, such as an RFID reader, for        detecting a type of staple cartridge prior to loading the staple        cartridge in the instrument, the staple cartridge having an a        code or tag, such as an RFID tag.

In some embodiments, the power pack presets the motor to correspond tothe type of staple cartridge detected. The type of staple cartridgedetected can be a length of a linear array of staples within thecartridge and/or a size of the staples within the cartridge.

In some embodiments, a motor in the power pack for firing staples cannotbe actuated if the reader detects the staple cartridge has already beenfired.

In some embodiments, the surgical fastener applier has a window adjacentthe housing exhibiting a desired clamp force dependent on the type ofcartridge and/or the type of cartridge selected.

In accordance with another aspect of the present invention, a surgicalfastener applier is provided comprising:

-   -   a housing containing a compartment therein, the compartment        having an openable cover to provide access to the compartment        for removably loading a power pack having a motor, a first        switch and a second switch;    -   an elongated member extending distally from the housing;    -   a first jaw and a second jaw adjacent a distal portion of the        elongated member, at least the first jaw movable with respect to        the second jaw to clamp tissue between the first and second        jaws;    -   a fastener firing mechanism positioned within the housing, the        firing mechanism movable by the first motor of the power pack        loaded into the compartment, the firing mechanism movable        between a first position and a second position, wherein in the        second position, the firing mechanism effects firing of        fasteners into the tissue clamped between the first and second        jaws, the firing mechanism actuated by the first switch; and    -   an articulation mechanism movable between a first position to a        second position to angle the first and second jaws to an angled        position with respect to a longitudinal axis of the elongated        member, the articulation mechanism actuated by a second switch;    -   wherein the first switch cannot be activated if the second        switch is activated and the second switch cannot be activated if        the first switch is activated.

In some embodiments, the power pack has a first drive mechanismengageable with the firing mechanism, and the power pack cannot beremoved from the compartment if the first drive mechanism in not in ahome position. In some embodiments, the power pack has a second drivemechanism engageable with the articulation mechanism, and the power packcannot be removed from the compartment if the articulation mechanism innot in a home position.

In some embodiments, opening of the jaws disables a firing mode. In someembodiments, closing of the jaws disables an articulation mode.

In accordance with another aspect of the present disclosure, a surgicalfastener applier is provided comprising:

-   -   a housing containing a compartment therein;    -   an elongated member extending distally from the housing;    -   a first jaw and a second jaw at a distal portion of the        elongated member, at least the first jaw movable with respect to        the second jaw to clamp tissue between the first and second        jaws;    -   a firing mechanism positioned within the housing, the firing        mechanism movable between a first position and a second        position, wherein movement to the second position effects firing        of fasteners into the tissue clamped between the first and        second jaws; and    -   a power pack removably loadable into the compartment, the power        pack having a) a first motor and a first engagement member        removably engageable with the firing mechanism when the power        pack is loaded into the compartment to effect movement of the        firing mechanism from the first position to the second position,        the first engagement having a home position and an advanced        position; and b) a second motor and a second engagement member        removably engageable with an articulating mechanism in the        housing of the surgical fastener applier to effect movement of        an articulation mechanism to effect articulation of the first        and second jaws from a linear position to a position angled with        respect to a longitudinal axis of the elongated member, the        second engagement member having a home position and an advanced        position, wherein the power pack can be loaded into the        compartment only if the first and second engagements are in the        home position.

In some embodiments, the power pack can be removed from the compartmentonly if the first and second engagement members are in the homeposition.

In some embodiments, neither a firing switch nor an articulation switchcan be activated if the cover is not in the closed position.

In accordance with another aspect of the present invention, a method forpowering a surgical stapler is provided comprising:

-   -   a) providing a surgical stapler having first and second jaws, an        elongated shaft and a housing containing a compartment;    -   b) loading a reusable power pack into a homing cradle so an        articulation mechanism and a firing mechanism within the power        pack are in a home position, the power pack having a first motor        for firing staples and a second motor for articulation of the        jaws; and    -   c) after step (b) removing the power pack from the homing cradle        and placing the power pack into the compartment of the housing;        and    -   d) wherein the powertrain cannot be loaded into the compartment        if the articulation mechanism and the firing mechanism are not        in the home position.

In some embodiments, the firing mode cannot be effected if a cover ofthe compartment is not in the closed position. In some embodiments, thepower pack cannot be removed from the compartment if the articulationmechanism and the firing mechanism are not in the home position. In someembodiments, a switch for actuating the firing mechanism cannot beactuated if a switch for the articulation mechanism is activated. Insome embodiments, a switch for actuating the articulation mechanismcannot be actuated if a switch for the firing mechanism is activated.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1 is a perspective view of a first embodiment of the surgicalstapler of the present disclosure having a removable power pack;

FIG. 2A is a side view of the surgical stapler of FIG. 1 ;

FIG. 2B is a bottom view of the surgical stapler of FIG. 1 ;

FIG. 2C is a front view of the surgical stapler of FIG. 1A:

FIG. 3A is a perspective view of the surgical stapler of FIG. 1 showingthe handle compartment cover in the open position and further showingthe power pack prior to insertion into the handle compartment;

FIG. 3B is front view of the surgical stapler of FIG. 3A showing thehandle compartment cover in the open position;

FIG. 3C is a front view of the power pack of FIG. 3A;

FIG. 3D is a top perspective view of the surgical staple of FIG. 3Ashowing the compartment for receiving the power pack;

FIG. 4A is a top view of the motor and drive mechanism (assembly) of thepower pack of FIG. 3A;

FIG. 4B is a side view of the motor and drive mechanism of the powerpack of FIG. 4A;

FIG. 4C is a top view of the power pack of FIG. 3A;

FIG. 4D is a side view of the motor and drive mechanism of FIG. 4A shownengaged with the rod of the firing assembly of the surgical stapler ofFIG. 1 ;

FIG. 4E is a perspective view of the motor and drive mechanism of thepower pack of FIG. 3A;

FIG. 4F is a cross-sectional view taken along line AY-AY of FIG. 4Cshowing the power pack engaging the firing rod of the surgical staplerof FIG. 1 ;

FIG. 4G is a side view of the power pack of FIG. 3A;

FIG. 4H is a cross-sectional view taken along line AT-AT of FIG. 4G;

FIG. 4I is a top view of the surgical stapler of FIG. 1 ;

FIG. 5A is a schematic view illustrating transition from rotationalmovement to linear movement to effect a function of the surgicalstapler;

FIG. 5B is a schematic view of an alternate embodiment illustratingtransition from rotational movement to linear movement to rotationalmovement to effect a function of the surgical stapler;

FIG. 6A is a side view of the surgical stapler of FIG. 1 showing thehandle compartment cover in the open position and further showing thepower pack in the process of being inserted in the compartment of thehandle;

FIG. 6B is a bottom view of the surgical stapler of FIG. 6A;

FIG. 6C is a cross-sectional view taken along line A-A of FIG. 6B;

FIG. 6D is a close up view of the area of detail AR of FIG. 6C;

FIG. 7A is a top view of the surgical stapler of FIG. 1 with the powerpack fully inserted into the compartment in the handle and the cover inthe closed position;

FIG. 7B is a cross-sectional view taken along line A-A of FIG. 7A;

FIG. 7C is a close up view of the area of detail B of FIG. 7B showingthe firing mechanism at the distal end for firing staples;

FIG. 8A is a top view of the surgical stapler of FIG. 1 showing thepower pack fully inserted and the cover of the handle compartment in theclosed position, the view the same as FIG. 7A but having section lineE-E;

FIG. 8B is a cross-sectional view taken along line E-E of FIG. 8A, theview being the same as FIG. 7B but having section lines F-F andidentified area of detail B;

FIG. 8C is a side view of the surgical stapler of FIG. 1 showing thepower pack fully inserted in the handle compartment and the compartmentcover closed;

FIG. 8D is a cross-sectional view taken along line J-J of FIG. 8C;

FIG. 9 is a cross-sectional view taken along line F-F of FIG. 8B;

FIG. 10 is a close up view of the area of detail G of FIG. 8B;

FIG. 11 is a close up view of the area of detail H of FIG. 9 ;

FIG. 12 is a close up view of the detail K of FIG. 8D;

FIG. 13A is a side view of an alternate embodiment of the surgicalstapler showing the power pack of FIG. 3A prior to insertion into thehandle compartment;

FIG. 13B is a side view similar to FIG. 13A showing the power pack ofFIG. 3A inserted into the handle compartment;

FIG. 13C is a side view of another alternate embodiment of the surgicalstapler showing the power pack of FIG. 3A prior to insertion into thehandle compartment;

FIG. 13D is a side view similar to FIG. 13C showing the power pack ofFIG. 3A inserted into the handle compartment;

FIG. 14A is a side view illustrating an alternate embodiment having apower pack for effecting both firing and articulation of the surgicalstapler, the power pack shown fully inserted into the compartment of thehandle of the surgical stapler and the compartment cover shown in theclosed position;

FIG. 14B is a top view of the surgical stapler of FIG. 14A;

FIG. 14C is a cross-sectional view taken along line C-C FIG. 14B;

FIG. 14D is a side view of the surgical stapler of FIG. 14A, the viewbeing the same as FIG. 14A but having section line M-M;

FIG. 14E is cross-sectional view taken along line M-M of FIG. 14D;

FIG. 14F is a cross-sectional view taken along line N-N of FIG. 14D;

FIG. 15A is a close up view of the area of detail D of FIG. 14C;

FIG. 15B is a close up view of the area of detail O of FIG. 14E:

FIG. 15C is a top view of the power pack of FIG. 14A for effecting bothfiring and articulation of the surgical stapler;

FIG. 15D is a cross-sectional view taken along line AW-AW of FIG. 15C;

FIG. 15E is a side view of the power pack of FIG. 14A;

FIG. 15F is a cross-sectional view taken along line AT-AT of FIG. 15E;

FIG. 16A is a top view of the surgical stapler of FIG. 14A, the viewbeing the same as FIG. 14B but having section line E-E;

FIG. 16B is a side view of the surgical stapler of FIG. 14A, the viewbeing the same as FIG. 14C but having section line F-F and identifiedarea of detail G;

FIG. 16C is a cross-sectional view taken along line F-F of FIG. 15C;

FIG. 16D is a close up view of the area of detail H of FIG. 16C;

FIG. 17 is a side view of the surgical stapler of FIG. 14A, the viewbeing the same as FIG. 14A but having section line J-J;

FIG. 18A is a cross-sectional view taken along line J-J of FIG. 17 ;

FIG. 18B is a close up view of the area of detail BA of FIG. 18A;

FIG. 19A is a top cutaway view of the power pack of FIG. 14A;

FIG. 19B is an enlarged view of the area of detail AK of FIG. 19A;

FIG. 19C is an enlarged view of the area of detail AL of FIG. 19A;

FIG. 20 is a cross-sectional side view of the surgical stapler of FIG.14A, the view being the same as FIG. 14C but having identified areas ofdetail Q, R and S;

FIG. 21A is an enlarged view of the area of detail Q of FIG. 20 ;

FIG. 21B is an enlarged view of the area of detail R of FIG. 19A;

FIG. 21C is an enlarged view of the area of detail S of FIG. 19A;

FIG. 22A is a top view of the motor and drive mechanism (assembly) ofthe power pack of FIG. 14A for effecting staple firing and articulation;

FIG. 22B is a side view of the motor and drive mechanism of the powerpack of FIG. 14A;

FIG. 22C is a side view of the motor and drive mechanism of FIG. 14Ashown engaged with the articulation rod of the articulation assembly ofthe surgical stapler of FIG. 14A;

FIG. 22D is a perspective view of the motor and drive mechanism(assembly) of the power pack of FIG. 14A;

FIG. 23A is a cross-sectional side view of the surgical stapler of FIG.14A, the view being the same as FIG. 18A but having and identified areaof detail AU;

FIG. 23B is an enlarged view of the area of detail AU of FIG. 23A;

FIG. 24A is a top view of the motor and drive mechanism (assembly) ofthe power pack of an alternate embodiment having a belt drive;

FIG. 24B is a side view of the motor and drive mechanism of FIG. 24A;

FIG. 24C is a perspective view of the motor and drive mechanism of FIG.24A;

FIG. 24D is a front view of the motor and drive mechanism of FIG. 24A;

FIG. 25A is a top view of the motor and drive mechanism (assembly) ofthe power pack of an another alternate embodiment having a belt drive;

FIG. 25B is a side view of the motor and drive mechanism of FIG. 25A;

FIG. 25C is a perspective view of the motor and drive mechanism of FIG.25A;

FIG. 25D is a front view of the motor and drive mechanism of FIG. 25A;

FIG. 26A is a top view of the motor and drive mechanism (assembly) ofthe power pack of another alternate embodiment having a belt drive;

FIG. 26B is a side view of the motor and drive mechanism of FIG. 26A;

FIG. 26C is a perspective view of the motor and drive mechanism of FIG.26A;

FIG. 26D is a front view of the motor and drive mechanism of FIG. 26A;

FIG. 27A is a top view of the motor and drive mechanism (assembly) ofthe power pack of an alternate embodiment having a belt drive;

FIG. 27B is a side view of the motor and drive mechanism of FIG. 27A;

FIG. 27C is a perspective view of the motor and drive mechanism of FIG.27A;

FIG. 27D is a front view of the motor and drive mechanism of FIG. 27A;

FIG. 27E is a view similar to FIG. 27B showing engagement with thestapler firing rod;

FIG. 28A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being a circular stapler;

FIG. 28B is a side view of the circular stapler of FIG. 28A;

FIG. 28C is a perspective view of the circular stapler of FIG. 28A;

FIG. 28D is a front view of the circular stapler of FIG. 28A;

FIG. 29A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being an open surgery linearstapler;

FIG. 29B is a side view of the linear stapler of FIG. 29A;

FIG. 29C is a perspective view of the linear stapler of FIG. 29A;

FIG. 29D is a front view of the linear stapler of FIG. 29A;

FIG. 30A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being a flexible endoscopic linearstapler;

FIG. 30B is a side view of the linear stapler of FIG. 30A;

FIG. 30C is a perspective view of the linear stapler of FIG. 30A;

FIG. 30D is a front view of the linear stapler of FIG. 30A;

FIG. 31A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being an endoscopic clip applier;

FIG. 31B is a side view of the clip applier of FIG. 31A;

FIG. 31C is a perspective view of the clip applier of FIG. 31A;

FIG. 31D is a front view of the clip applier of FIG. 31A;

FIG. 32A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being an endoscopic grasper;

FIG. 32B is a side view of the endoscopic grasper of FIG. 32A;

FIG. 32C is a perspective view of the endoscopic grasper of FIG. 32A;

FIG. 32D is a front view of the endoscopic grasper of FIG. 32A;

FIG. 33A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being an endoscopic scissor;

FIG. 33B is a side view of the endoscopic scissor of FIG. 33A;

FIG. 33C is a perspective view of the endoscopic scissor of FIG. 33A;

FIG. 33D is a front view of the endoscopic scissor of FIG. 33A;

FIG. 34A is a top view of an alternate embodiment of the surgicalinstrument containing the power pack of FIG. 3A within the handlecompartment, the surgical instrument being a fastener applier;

FIG. 34B is a side view of the fastener applier of FIG. 34A;

FIG. 34C is a perspective view of the fastener applier of FIG. 34A;

FIG. 34D is a front view of the fastener applier of FIG. 34A;

FIG. 35 is a perspective view of an alternate embodiment of the surgicalinstrument of the present invention having a replaceable battery pack;

FIG. 36 is a perspective view of another alternate embodiment of thesurgical instrument of the present invention having a replaceablebattery pack;

FIG. 37A is a perspective view of another alternate embodiment of thesurgical instrument of the present invention having a replaceablebattery pack;

FIG. 37B is a side view of the surgical instrument of FIG. 37A;

FIG. 37C is a perspective view of the surgical instrument of FIG. 37Ashowing the power pack and battery pack within the compartment of thesurgical instrument;

FIG. 38 is a concept diagram of readying the power train for use inaccordance with one embodiment of the present invention;

FIG. 39 is a concept diagram illustrating the relationship betweeninstrument jaw position and articulation and firing enabling;

FIGS. 40A, 40B and 40C shown the steps of use of the instrument of thepresent invention;

FIG. 41A is a side view of one embodiment of the handle portion of thesurgical instrument of the present invention illustrating the clampinghandle in the open position so the firing switch cannot be activated;

FIG. 41B is a side view of the clamping handle in the closed position sothe firing switch can be activated;

FIGS. 42A-43C illustrate alternate embodiments of the surgicalinstrument of the present invention having measurement devices toprovide feedback, wherein:

FIG. 42A is a side view of the surgical instrument;

FIG. 42B is a perspective view of the surgical instrument;

FIG. 42C is a top view of the surgical instrument;

FIG. 42D is a cross-sectional view taken along line A-A of FIG. 42C;

FIG. 42E is an enlarged view of the area of detail B of FIG. 42D;

FIG. 42F is an enlarged view of the area of detail C of FIG. 42D;

FIG. 43A is a cross-sectional view identical to the cross-sectional viewof FIG. 42D illustrated to identify the areas of detail E and F;

FIG. 43B is an enlarged view of the area of detail E of FIG. 43A;

FIG. 43C is an enlarged view of the area of detail F of FIG. 43A;

FIG. 44A is a cross-sectional view identical to the cross-sectional viewof FIG. 42D illustrated to identify the areas of detail H and I;

FIG. 44B is an enlarged view of the area of detail I of FIG. 44A;

FIG. 44C is an enlarged view of the area of detail H of FIG. 44A;

FIGS. 45A-45F illustrate an alternate embodiment of the surgicalinstrument of the present invention having a feedback feature(measurement device) in the power pack, wherein:

FIG. 45A is a top view of the surgical instrument with the power packbeing loaded into the instrument;

FIG. 45B is a cross-sectional view taken along line J-J of FIG. 45Ashowing the power pack being loaded into the instrument;

FIG. 45C is an enlarged view of the area of detail K of FIG. 45B;

FIG. 45D is a top view of the surgical instrument with the power packloaded into the instrument;

FIG. 45E is a cross-sectional view taken along line L-L of FIG. 45Ashowing the power pack in the instrument;

FIG. 45F is an enlarged view of the area of detail M of FIG. 45E;

FIG. 46 is a perspective view of components within the handle assemblyin accordance with an alternate embodiment;

FIG. 47 is a perspective view of the components of FIG. 46 (with thehandle housing removed);

FIG. 48 is a sectional view of the components of FIG. 46 (with thehandle housing removed);

FIG. 49 is an enlarged side view illustrating a cam slot arrangement forclosing the jaws of the instrument, the cartridge jaw shown in the open(unclamped) position;

FIG. 49 is top view of the jaw assembly;

FIG. 50 is a cross-sectional view taken along line K-K of FIG. 49showing the cartridge jaw in the open unclamped position;

FIG. 51 is an enlarged view of the area of detail designated in FIG. 50;

FIG. 52 is a block diagram depicting various measurement devices;

FIG. 53 is a flow chart depicting utilization of a dummy cartridge tomeasurement;

FIG. 54 is a flow chart depicting motor speed adjustment based onmeasurements.

FIG. 55 is a perspective view of an alternate embodiment of the powerpack of the present invention;

FIG. 56 is a top view of the power pack of FIG. 55 ;

FIG. 57A is a cross-sectional view taken along line A-A of FIG. 56 ;

FIG. 57B is an enlarged view of the area of detail B of FIG. 57A;

FIG. 57C is an enlarged view of the area of detail C of FIG. 57A;

FIG. 58 is a perspective of the deployment (firing) screw assembly ofthe power pack of FIG. 55 ;

FIG. 59 is a side view of the assembly of FIG. 58 ;

FIG. 60A is an enlarged view of the area of detail D of FIG. 59 ;

FIG. 60B is a cross-sectional view taken along line E-E of FIG. 6 o A;

FIG. 61A is an enlarged view of the area of detail F of FIG. 59 ;

FIG. 61B is a cross-sectional view taken along line G-G of FIG. 61A;

FIG. 62A is a cross-sectional view taken along line H-H of FIG. 56 ;

FIG. 62B is an enlarged view of the area of detail I of FIG. 62A;

FIG. 62C is an enlarged view of the area of detail K of FIG. 62A;

FIG. 63 is a perspective of the articulation screw assembly of the powerpack of FIG. 55 ;

FIG. 64 is a side view of the assembly of FIG. 63 ;

FIG. 65A is an enlarged view of the area of detail L of FIG. 64 ;

FIG. 65B is a cross-sectional view taken along line M-M of FIG. 65A;

FIG. 66A is an enlarged view of the area of detail N of FIG. 64 ;

FIG. 66B is a cross-sectional view taken along line O-O of FIG. 66A;

FIG. 67 is side view of the power pack in accordance with an alternateembodiment of the present invention having an encoder;

FIG. 68 is an exploded view of the deployment screw assembly and encoderof the power pack of FIG. 67 ;

FIG. 69A is a cross-sectional view taken along line P-P of FIG. 68 ;

FIG. 69B is an enlarged view of the area of detail Q of FIG. 69A;

FIG. 69C is a cross-sectional view taken along line R-R of FIG. 69A;

FIG. 69D is an enlarged view of the area of detail S of FIG. 69C;

FIG. 70 is a perspective view of the deployment screw assembly andencoder of the power pack of FIG. 67 ;

FIG. 71 is an enlarged view of the area of detail BK of FIG. 70 ;

FIG. 72 is a side view of the power pack of FIG. 67 showing section lineT-T;

FIG. 73A is a cross-sectional view taken along line T-T of FIG. 72 ;

FIG. 73B is an enlarged view of the area of detail V of FIG. 73A;

FIG. 74 is side view of the power pack of an alternate embodiment of thepresent invention having an encoder;

FIG. 75 is a cross-sectional view taken along line W-W of FIG. 74 ;

FIG. 76A is a cross-sectional view taken along line Y-Y of FIG. 74 ;

FIG. 76B is an enlarged view of the area of detail X of FIG. 75 ;

FIG. 76C is an enlarged view of the area of detail Z of FIG. 76A;

FIG. 77 is a perspective view of an alternate embodiment of the surgicalinstrument of the present invention having a cover to activate a switchof the power pack, the cover shown in an open position;

FIG. 78 is an enlarged view of the area of detail CB of FIG. 77 ;

FIG. 79 is a top perspective view of the instrument of FIG. 77 ;

FIG. 80 is an enlarged view of the area of detail CG of FIG. 79 ;

FIG. 81 is a side view of the surgical instrument of FIG. 77 ;

FIG. 82A is a rear view of the surgical instrument of FIG. 81 ;

FIG. 82B is a cross-sectional view taken along line CD-CD of FIG. 81 ;and

FIG. 83 illustrates a firing profile graph with line A representingmotor speed, line C representing the measured force and line Brepresenting the optimal force.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure provides power packs, containing a battery andpower train, which are loadable into a surgical stapler to power variousfunctions of the surgical stapler to reduce the forces exerted by theclinician otherwise required if manual force was utilized. The presentdisclosure also provides surgical staplers designed to receive the powerpack and to interact with the power pack to effect firing of thestaplers. In some embodiments, the power pack can be used to effectarticulation of the jaw assembly of the stapler to pivot the jawassembly with respect to the longitudinal axis of the stapler. Each ofthese embodiments is discussed in detail below.

The power pack can also be utilized for powering endoscopic linearstaplers, other types of staplers as well as other surgical instruments.Examples of these instruments are also discussed below.

The loadable power packs of the present disclosure are mountable intothe handle housing of the surgical instrument, and are maintained in asterile environment within the surgical instrument so they can beremoved and reused. This enables the power pack to be removed from thestapler and reused in another procedure and/or instrument without thecomplexities, time, costs and risks of resterilization of the powerpack. The sealed environment of the battery and power train within thehousing also enables certain features/components to be used which mightnot otherwise be practical if sterilization of the internal power packwas required. Thus, by preventing contact between the power pack and thepatient and/or bodily fluids and the external environment,resterilization is not required. The power pack can be used withsurgical instruments discarded after use (fully disposable instruments),partially disposable surgical instruments or with fullyreusable/sterilizable instruments with the advantage that the power packneed not be discarded or sterilized. Thus, the surgical stapler of thepresent disclosure advantageously reduces the time, resources and/orcosts for preparing the surgical stapler for its next use.

The power packs are easily loadable in the surgical instrument,preferably the handle assembly or housing of the instrument, to easilyand securely engage structure in the housing to effect movement of suchstructure in the instrument. The power packs are also easilydisengageable from the structure for removal from the housing forsubsequent reuse. The power packs can be configured so they can beloadable and engageable in various types of surgical instruments. Thepower pack is fully enclosed and sealed by the handle housing so thereis no need to sterilize the power pack between uses. The power pack caninclude a replaceable battery pack so the battery can be changed duringa surgical procedure.

In some embodiments the power packs includes sensors, encoders ormeasurement devices to assess/detect certain functions of the surgicalinstruments. In some embodiments, automatic adjustments are made via amicroprocessor in the power pack to account for such assessment anddetection.

Referring now to the drawings and particular embodiments of the presentdisclosure, wherein like reference numerals identify similar structuralfeatures of the devices disclosed herein, there are illustrated severalembodiments of the surgical instruments and removable power pack of thepresent disclosure.

With reference to FIGS. 1-23B, the power pack is used with endoscopiclinear staplers which are inserted through trocars and fire linear rowsof surgical staples from a cartridge through tissue into contact with ananvil which forms the individual staples. The staplers include anopenable compartment in the handle housing that enables easy loading ofthe power pack within the stapler. The staplers also provide a tightseal to protect the power pack from contaminants so that the power packdoes not need to be sterilized for multiple uses.

The power pack is engageable with a staple drive (staple firing)mechanism of the surgical stapler so that once it is loaded in thestapler, actuation of the motor within the power pack effects firing ofthe staples through tissue. In some embodiments, the power pack isengageable with an articulation mechanism wherein actuation of the motoreffects articulation of the stapler. The powered articulation can be inaddition to the powered staple firing or alternatively the stapler couldhave powered articulation and manual staple firing. A specificembodiment of such powered articulation included with powered firing isshown in FIGS. 14A-23B and discussed in detail below.

The term “surgical fasteners” as used herein encompasses staples havinglegs which are deformed by an anvil, two part fasteners wherein afastener or staple component with legs is received and retained in asecond component (retainer), and other types of fasteners which areadvanced through tissue of a patient in performing surgical procedures.

The term “proximal” as used herein denotes the region closer to the userand the term “distal” as used herein denotes the region further from theuser. The terms “top” or “upper” and “bottom” or “lower” refer to theorientation of the instruments as shown in the orientation of theinstrument in FIG. 2A, with the cover being on the top and the handleextending at the bottom.

Turning first to FIGS. 1-12 , a first embodiment of the surgical staplerand removable power pack are illustrated. In this embodiment, the powerpack, which contains a battery, motor, drive mechanism and staplerengagement structure, effects firing of the surgical fasteners(staples).

The surgical stapler, also referred to herein as the or surgicalfastener applying instrument or surgical fastener applier, is designatedgenerally by reference numeral 1 and includes a proximal portion 1 a, adistal portion 1 b and an elongated or endoscopic portion 6 (alsoreferred to as an elongated tubular portion or shaft) extending betweenthe proximal portion 1 a and the distal portion 1 b. A handle assembly 2with a housing 4 (also referred to herein as a handle housing) ispositioned at the proximal portion 1 a and is configured to house andprotect internal mechanisms of the stapler including the removable powerpack when loaded (mounted) therein. At the distal portion 1 b areopposing members, i.e., jaws, 8 a, 8 b, configured to clamp andconstrain tissue during operation of the surgical stapler. At least oneof the jaws is movable with respect to the other jaw from an openposition to receive tissue between the jaws and a closed position toclamp tissue between the jaws. Thus, one of the jaws can be stationaryand the other jaw movable with respect to the stationary jaw oralternatively both jaws can move, e.g., pivot, toward each other. In theembodiment of FIG. 1 , jaw 8 b, which contains at least one row ofsurgical fasteners (staples) is movable with respect to non-pivoting(stationary) jaw 8 a which contains an anvil with staple formingpockets. Jaws 8 a, 8 b are collectively referred to herein as jaws 8.The fasteners are fired (advanced) from jaw 8 b by linear movement of afiring mechanism which engages staple drivers within the jaw 8 b whichmove transverse to the longitudinal axis, i.e., transverse to thedirection of movement of the firing mechanism, to sequentially advance(from proximal to distal) the staples in the linear rows of staples fromthe jaw 8 b and through tissue to engage the anvil pockets on jaws 8 afor formation of the staples. Such firing of the staples is illustratedin FIG. 7C and discussed below.

The elongated tubular member 6 extends distally from the housing 4 andis configured to fit through a surgical port (trocar) used forlaparoscopic surgery. The endoscopic portion 6 can be of varyingdimensions and in some embodiments is configured to fit through a 10 mmtrocar, although other dimensions for fitting through other size trocarsare also contemplated such as trocars ranging from 5 mm to 15 mm. It isadvantageous to minimize the diameter of the endoscopic portion tominimize the size of the patient's incision. With the jaws 8 in theclamped position, the outer diameter of the elongated member 6 ismaintained as the cross-sectional dimension of the closed jaws 8preferably does not exceed the cross-sectional dimension (i.e.,diameter) of the tubular member 6.

The surgical stapler 1 can in some embodiments include a joint 10 thatprovides for the articulation of the opposing members 8, i.e., pivotingof the jaw assembly (jaws 8) to angular positions with respect to thelongitudinal axis of elongated member 6. Articulation can be achieved bylinear motion of elongated members extending through the endoscopicportion 6 which are slidable to angle the jaw assembly. A rotationalmember or knob 12 is configured to rotate, with respect to the handleassembly, the elongated member 6 and connected jaws 8 about the axis ofthe elongated member 6 to change the position of the jaws 8.Articulation is effected by manual manipulation of a lever adjacent thehandle 2. A handle lever 14, linked to an axially movable clamping bar,is pivotable from a first position to a second position closer tostationary handle 16 to effect movement of the jaw 8 b toward the jaw 8a from an open (unclamped) position to a clamping position, alsoreferred to as a closed position of the jaws 8. Release of handle lever14 returns the jaw 8 b to its open position. Stationary handle 16 forgrasping by the user is ergonomically designed for comfort of use. Insummary, the surgical stapler operates by manual pivoting of the lever14 toward stationary handle 16 to clamp the tissue between jaws 8,followed by powered firing of the staples from jaw 8 b, through theclamped tissue and into contact with the staple forming pockets of theanvil of jaw 8 b. Prior to firing, the jaws 8 can be rotated to adesired orientation by rotation of endoscopic portion 6 via knob 12and/or articulated about joint 10, via movement of the elongatedarticulation members, to a desired angled position with respect to thelongitudinal axis of endoscopic portion 6. In the embodiment of FIG. 1 ,articulation is performed by manual manipulation of a lever (not shown)which is operatively connected to an internal elongated member withintubular member 6 which extends to joint 10. A force applied to theinternal elongated member pivots/articulates the jaws 8 about the joint10. In later described embodiments (FIG. 14A), powered articulation isprovided.

The housing 4 of the handle assembly 2 of the surgical stapler isconfigured to receive the loadable/removable power pack 18 in areceptacle (compartment) 20 as shown in FIGS. 3A and 3D. The receptacleincludes a base 25 a and side walls 25 b and 25 c having one or moreguides 23 that cooperate with corresponding guiding structures 28 on theouter wall of the housing 19 of power pack 18 for proper alignment ofthe power pack 18 in the handle assembly 2 during insertion into thereceptacle 20. In the embodiment of FIG. 3A, the guides 28 on power packhousing 19 are in the form of a pair of ribs or projections 28 extendingtransversely to a longitudinal axis of the power pack 18 for receiptwithin grooves formed between guides, e.g., ribs or projections, 23 ofthe compartment 20, also extending transversely with respect to alongitudinal axis of the stapler 1. In the illustrated embodiment, theribs 23 are on opposing sides of the power pack 18 and are axiallyoffset from each other, although in alternate embodiments they can beaxially aligned. Additionally, a different number of ribs (axially ornon-axially aligned) can be provided (with corresponding receivingstructure in the compartment 20). It should be appreciated thatalternatively, the grooves could be provided on the power pack 18 andthe ribs provided in the compartment 20 to provide the guiding structurefor the power pack 18. The guiding structure also helps to retain powerpack 18 in position within the compartment 20. The power pack 18 hasfront and rear concave regions 19 a, 19 b to reduce its overall size.

The handle assembly 2 includes a cover 22 for opening and closing thereceptacle 20. The compartment cover 22 is shown as being hingedlyattached to the housing 4, but may alternatively be fully removable orattached in some other manner such as a slidable connection or the like.The cover 22 is shown pivotable mounted to a top portion of the housing4 (in the orientation of FIG. 2A) for top loading of the power pack,although alternatively, side or bottom loading can be provided. Thecover 22 is shown pivotable from a closed position of FIG. 2A to an openposition of FIG. 3A to enable loading of power pack into the compartment20 of the housing 4. In some embodiments, the cover is spring loaded toan open position so it remains open for loading of the power pack 18.Once loaded, the cover 22 is pivoted about hinge 22 a to its closedposition. A latch can be provided to latch the cover 22 to the housing 4in the closed position. When the cover 22 is in an open position, e.g.,as shown in FIG. 3A, the power pack 18 may be removed from thereceptacle 20 or inserted into the receptacle 20.

When the cover 22 is in a closed position, the seal of the cover 22 isin contact with the rim of the housing 2 such that the receptacle 20,and the power pack 18 if inserted into the receptacle 20, is sealed fromthe environment exterior to the surgical stapler. The top seal 24 can beattached to the cover 22 and in some embodiments can be in the form ofan elastomer that is compressed by the housing, e.g., tightly fitsslightly within the housing or is pressed on the rim of the housing 2.In other embodiments, the elastomer seal 24 can be on the housing 2,i.e., extending around the perimeter of the rim of the compartment 20,and is compressed by the cover 22 to seal between the cover 22 andhousing 4. Other seals can also be provided within the surgical staplerto seal/protect the power pack 18 from contaminants, e.g., body fluids.These seals are discussed in more detail below.

Turning now to the power pack of the present disclosure, and withreference to FIGS. 4A-4I, the power pack 18 includes a motor assembly,battery and electronics contained within housing 19. More specifically,as shown in FIGS. 4A-4E, the power pack 18 includes a powering assemblyincluding a motor 32 connected to a planetary gear box 34 configured togear down the output of the motor 32 for proper drive speeds for firingstaples from jaw 8 b through the tissue into contact with the anvil ofjaw 8 a. The planetary gear box 34 drives a lead screw 36 through one ormore gears operatively connected to the motor shaft. More specifically,upon rotation of the motor shaft by motor 32 in a first direction, gear38 is rotated in the same first direction, causing rotation of the gear30 in a second opposite direction due to the intermeshed teeth of gears30 and 38. Lead screw 36 is operatively connected to gear 30 so thatrotation of gear 30 causes rotation of lead screw 30 in the samedirection. The power pack 18 includes a battery 33 which can berechargeable outside the stapler when the power pack 18 is removed. Thepower pack 18 in some embodiments can include a power switch which isactivated, i.e., turned on, by the clinician to start the motor andeffect staple firing. In other embodiments, the motor can automaticallyturn on when the power pack is fully loaded or upon actuation of anothercontrol on the stapler housing 4. In some embodiments, the motor canautomatically turn off when the power pack is removed from the staplerhousing.

Connected to the end of lead screw 36 (the end opposite the connectionto the gear 30) is a drive mechanism 40. The drive mechanism 40 isconfigured to move in a linear motion (in an axial direction) along thelead screw 36 in response to rotation of the lead screw 36. For example,the drive mechanism 40 may include internal threads that engage externalthreads of the lead screw 36 and may include slides engaged in a trackthat prevent the drive mechanism 40 from rotating and therefore causethe drive mechanism 40 to move linearly (axially) in response torotation of the lead screw 36. As depicted in FIGS. 4A-4G, the powerpack 18 has a compact configuration as the lead screw 36 extendsalongside, slightly spaced from, the motor 32 and gear box 34, i.e.,both the motor 32/gear box 34 and lead screw 36 extending longitudinallywith the lead screw 36 parallel to the motor 32. The drive mechanism 40is connected to a proximal end of lead screw 36 and extends proximallyof the proximal end of the motor 32 in the illustrated embodiment.

The power pack 18 can have features/structure to constrain the motor 32.In the embodiment of FIG. 4F, such feature is in the form of proximalrails 27 a and distal rails 27 b spaced apart axially within the housing19. Motor 32 is seated within proximal rails 27 a and gear box 34 isseated within rails 27 b, the rails 27 a, 27 b retaining the motor andpreventing axial and rotational movement within the housing 19. Bearingor bushings 27 c and 27 d can also be provided to constrain the leadscrew 36 at opposing ends, while allowing rotation thereof, thereby alsoconstraining the motor. Other features can additionally or alternativelybe provided to restrain the motor from axial movement while allowingrotation of the lead screw.

The drive mechanism 40 includes a first output flag or yoke 42, which isdiscussed in more detail below, configured to engage a staple firingmechanism, e.g., firing rod 46, extending longitudinally within thehandle 4. The staple firing rod 46 is operatively connected to a firingrod in the endoscopic portion 6 which is operatively engageable with aseries of staple drivers in jaw 8 b to advance the fasteners (staples)from the fastener jaw 8 b. Alternatively, the firing rod 46 can extendthrough the endoscopic portion 6 and itself engage the stapler driversas shown in FIG. 7C. Thus, as the motor 32 generates rotational motionof the lead screw 36 through the planetary gear box 34 and the gears 38,30, the drive mechanism 40 moves in linear motion along the lead screw36. Such linear motion effects linear movement of the firing rod 46 (dueto the engagement by the flag 42) which advances the staple drivingmechanism to advance (fire) the staples out from jaw 8 b through tissueand into contact with the anvil in jaw 8 a. As noted above, the firingrod 46 can be a single element extending through the endoscopic portion6 (see e.g., FIG. 7C) and terminating adjacent jaws 8 or alternativelycan be attached to one or more components intermediate the firing rod 46and jaws 8. In FIG. 7C, camming surface 46 a of firing rod 46 engagesstaple drivers 47 to sequentially fire staples 51 as the firing rod 46is advanced.

The power pack 18 can also include in some embodiments one or moresensors to indicate the position of the firing rod 46 to indicate to theclinician the status of staple firing. The embodiment of FIG. 4Fillustrates an example of such sensors if they are provided. The powerpack 18 has within the housing a proximal sensor 39 a and a distalsensor 39 b to sense the position of yoke 42 of the drive mechanism 40.Thus, sensor 39 a senses the initial position of the yoke 42 (and thusthe initial position of the firing rod 46) and at the end of the firingstroke, sensor 39 b would indicate the end (final) position of the yoke42 (and thus the final positon of the firing rod 46) which wouldindicate completed firing of the fasteners. The power pack 18 could alsoinclude an audible or visual indicator (viewable though the power packhousing 19 and instrument handle housing 4) actuated by the sensor toindicate to the clinician the position of the flag 42 and thus thecompletion or status of the firing stroke to fire the fasteners. Thepower pack 19 can also include sensors to detect the position of thearticulation flag in the embodiments discussed below which have poweredarticulation. The sensor can include a potentiometer to determine thelocation during the firing stroke. It can also include an encoder todetect the position along the stroke. Alternatively, the stroke can alsobe identified by motor count. The power pack 18 in all other respects isidentical to power pack 18 of FIG. 3A.

It is also contemplated that in alternate embodiments, the sensor(s) canbe carried by the handle housing rather than (or in addition to) thepower pack and utilized to detect the positioning of the flag 42 and/orfiring rod 46 and/or detect the position of the articulation flag and/orarticulation rod in the embodiments discussed below which have poweredarticulation.

It is also contemplated that a sensor(s) can be provided to detect theposition of the clamping rod for clamping the jaws. The sensor can beprovided in (or supported by) the power pack or alternatively thesensor(s) can be carried by the handle housing rather than (or inaddition to) the power pack and utilized to detect the positioning ofthe jaws by detecting the position of the flag engaging the jaw clampingrod and/or detecting the position of the jaw clamping rod in theembodiments which have powered clamping.

Note the sensor can be provided in some embodiments; in otherembodiments, no sensor is provided.

The power pack in some embodiments has a battery pack that is removablymounted in or on the power pack. This is discussed in more detail inconjunction with FIGS. 35-37C.

Turning now to the loading of the power pack 18 into the surgicalstapler 1, as seen in FIGS. 6A-6D, the power pack 18 is in the processof being inserted into the receptacle 20 of housing 4. As shown, handlecompartment cover 22 is open to provide access to compartment 20. Theoutput flag 42 of the power pack 18 as noted above is driven by themotor assembly and is configured to engage and interact with structurewithin the handle assembly 2, e.g., firing rod 46, to control operationof the surgical stapler 1 when the power pack 18 is fully inserted intothe receptacle 20. As can be appreciated in FIG. 6D, the output flag 42is not fully engaged with the flange 44 of the firing rod 46. Also shownin FIG. 6D is the clamp bar 49 which is positioned within and concentricwith firing rod 46. The clamp bar 49 is operatively connected to thepivotable handle 14 of stapler 1 via linkage 14 a (pin 14 b connects oneend of handle 14 to the distal end of clamp bar 49). In this manner,movement of pivotable handle 14 toward stationary handle 16 causes theoperatively connected jaw clamping mechanism, e.g., clamp rod 49, to beadvanced distally to pivot jaw 8 b toward jaw 8 a to clamp tissuebetween the two jaws 8. Note that for clamping, clamp bar 49 slideslinearly within a lumen of firing rod 46; for staple firing, firing rod46 moves linearly over clamp bar 49.

The output flag 42 of power pack 18 is configured to engage a bossed end44 of the firing rod 46 when the power pack 18 is fully inserted intothe receptacle 20 of the handle assembly 2. As shown, the output flag(yoke) 42 has a receiving or mounting feature or member (also referredto as the engagement feature (member) or firing rod engagement feature(member) in the form of two arms 43 a and a slot 43 b therebetween,configured to frictionally (and releasably) engage the bossed end 44,the feature aligning with the bossed end 44 during insertion. (Theaforedescribed guiding structure on the power pack 18 and internal wallof the compartment 20 aid such alignment).

FIGS. 8A, 8B and 10 show the power pack 18 fully inserted into thecompartment 20 of stapler 1. In this position, the output flag 42 isengaged with the bossed end 44 of the firing rod 46. Note the firing rod46 is able to rotate when the first output flag 42 of the power pack 18is engaged with the bossed end 44. When the power pack 18 is secured tothe firing rod 46 by the first output flag 42, linear motion generatedat the first output flag 42 by the motor actuated drive assembly istransferred to the firing rod 46, which moves linearly to actuate thestaple firing mechanism. That is, rotation of the gear 30 effects axial(linear) movement of the drive screw 36 which effects axial (linear)movement of the connected drive mechanism 40 to effect axial (linear)movement of the associated drive mechanism (rod) engaging member (i.e.,flag 42). It should be appreciated that flag 42 provides one example ofthe releasable attachment (engagement member) of the motor assembly tothe firing rod 46, it being understood that other mounting (engagement)members or features are also contemplated to engage the firing rod toadvance it axially.

In use, the cover 22 of stapler 1 is opened and the power pack 18 isinserted into receptacle 20 of sterile handle assembly 2 (of sterilestapler 1), with the output flag 42 of the power pack 18 engaging acorresponding feature, e.g., boss 44 of elongated drive rod 46, in thehandle assembly 2 as discussed above. Then, the cover 22 is closed toseal the power pack 18 within the receptacle 20 from the externalenvironment and the surgical stapler 1 may be actuated, i.e., manuallyclamped, articulated and/or rotated if desired, and the motor actuatedto effect staple firing. After applications of fasteners and release(unclamping of the jaws from tissue), the cover 22 can be opened and thepower pack 18 removed and charged while the stapler and handle assemblyare resterilized if the stapler is a reusable instrument or the staplerand handle assembly are disposed of if the stapler is a single usedisposable instrument. The power pack 18, due to its sealedconfiguration discussed above, can be reused without requiringsterilization by insertion into the receptacle 20 of a resterilizedhandle assembly or a sterile handle assembly of an unused disposablehandle assembly. Thus, as can be appreciated, the removable power pack18 does not need to be subjected to the sterilization process and,therefore, contact between the harsh temperatures and/or chemicals ofthe sterilization process is advantageously avoided. Also, by being ableto reuse the power pack without sterilization, significant cost savingsare achieved compared to if the power pack is not resterilizable, isdisposed of along with the disposable stapler.

Note that in the embodiment of FIGS. 1-12 (and FIGS. 14-23B discussedbelow), rotational motion caused by the motor is translated into linearmotion. This is shown schematically in FIG. 5A wherein the drive rod inthe handle housing is engaged by the motor driven drive assembly of thepower pack 18 (or power pack 90 which is discussed below) moves linearly(axially) to effect linear (axial) movement of the drive member in thestapler, e.g., extending through the endoscopic portion, which effectsstaple firing. Alternatively, or in addition, a drive assembly of thepower pack engages a drive rod in the housing which moves linearly toeffect linear movement of a drive rod to effect clamping of the jawsand/or a drive assembly of the power pack engages a drive rod in thehousing which moves linearly to effect linear movement of a drive memberto effect articulation of the jaw assembly. Alternatively, theintermediate drive member could be omitted and the drive rods directlyeffect respective clamping and articulation.

In an alternate embodiment, shown schematically in FIG. 5B, linearmotion is converted back to rotational movement. That is, the handlehousing has a receptacle (compartment) to receive power pack 18 (orpower pack 90) which has one or more engagement features to engage orcouple to a firing rod for firing staples, a clamping rod for clampingthe jaws about tissue and/or an articulation rod to articulate the jawsto angular positions with respect to the longitudinal axis. The driverod is connected at its distal end to a block in the stapler having afemale thread or a slotted guide engagement to prevent rotation of theblock and enable linear movement. (The drive rod could alternatively beattached to other structure). The block is connected to a male leadscrew which is engaged at its proximal end via threaded engagement tothe distal end of the block. The lead screw is connected at its distalend to a component that requires rotation to effect operation of thestapler, such as effecting staple firing, clamping and/or articulation.A bearing can be provided to keep the lead screw on center and controlaxial motion. In use, actuation of the motor advances the drive assemblyof the power pack linearly which is engaged with and advances the driverod in the handle housing linearly (axially). Linear movement of thedrive rod causes linear movement of the block positioned in theendoscopic portion (or alternatively positioned in the handle housing.)Linear movement of the block causes rotation of the male lead screw toengage a staple firing component(s) to effect staple firing.Alternatively, or in addition, the drive assembly, or a separate driveassembly (assemblies), engages a drive rod in the housing which moveslinearly to effect linear movement of a block to cause rotation of thelead screw to move a jaw clamping component(s) to effect clamping of thejaws and/or engages a drive rod in the housing which moves linearly toeffect linear movement of a block to cause rotation of the lead screw tomove an articulation component(s) to effect articulation of the jaws.

In the embodiment of FIGS. 1-12 , the power pack 18 actuates the firingrod 46 to fire the staples while other steps are performed manually. Insummary, in this embodiment, in use, the jaws 8 a, 8 b are moved to theclosed (clamped) position manually by a hand actuated lever or control.Also, in this embodiment, the jaws 8 are articulated with respect to thelongitudinal axis of the endoscopic portion manually by a hand actuatedlever or control. Thus, the clinician would manually clamp the jaws,manually rotate the endoscopic portion and attached jaws 8, and manuallyarticulate the jaws by manipulation of controls at the proximal end ofthe stapler 1, e.g., at the handle 4.

FIGS. 1-12 show one embodiment of an endoscopic linear stapler that canbe used with the power pack 19 of the present disclosure. However, thepower pack 18 is not limited to such endoscopic staplers. For example,FIGS. 13A and 13B illustrate another endoscopic linear stapler,designated by reference numeral 100, that can be powered by power pack18. Stapler 100 has a handle 102 manually pivotable towards stationaryhandle 103 for clamping of the jaws 108 a, 108 b, an endoscopic portion106 extending from the handle housing 101, a jaw assembly 104 containingjaws 108 a, 108 b and connector 107 a extending proximally from shaft ortube 107 for attachment to the endoscopic portion 106 so that the jawassembly 104 can be replaced multiple times in a single surgicalprocedure to provide additional rows of staples to tissue. The stapler100 also includes a rotation knob 109 for rotation of the endoscopicportion 106, with respect to the handle housing, to rotate the attachedjaws 108 a, 108 b. The stapler 100 can also include an articulation knobto articulate the jaws. Power pack 18 is shown in FIG. 13A prior toloading within the handle housing 101 and shown in FIG. 13B fully loaded(inserted) within the handle housing 101. A cover (not shown) can beprovided to seal the power pack 18 from the external environment. As inthe embodiment of FIGS. 1-12 , the flag 42 extending from lead screw 36engages a firing rod within the handle housing 101 to effect movement ofa firing rod to fire the staples when the motor of the power pack 18 isactuated. Power pack 90 having articulation described below can also beutilized with stapler 100.

FIGS. 13C and 13D illustrate another endoscopic linear stapler that canreceive the power pack 18. Endoscopic linear stapler 110 has a handle112 manually pivotable toward stationary handle 113 for clamping of thejaws 118 a, 118 b, an endoscopic portion 116 extending from the handlehousing 111, and a jaw assembly at the distal end of the endoscopicportion 116. The stapler 110 also includes a rotation knob 119 forrotation of the endoscopic portion 116 to rotate the jaws 118 a, 118 b.The stapler 110 can also include an articulation knob to articulate thejaws 118 a, 118 b. Power pack 18 is shown in FIG. 13C prior to loadingwithin the handle housing 112 and shown in FIG. 13D fully loaded(inserted) within the handle housing 112. A cover (not shown) can beprovided to seal the power pack 18 from the external environment. As inthe embodiment of FIGS. 1-12 , the flag 42 extending from lead screw 36engages a firing rod within the handle housing 111 to effect movement ofa firing rod to fire the staples when the motor of the power pack 18 isactuated. Power pack 90 having articulation described below can also beutilized with stapler 110.

FIGS. 30A-30D illustrate another type of endoscopic linear stapler thatcan receive and be powered by the power pack 18. Stapler 260 has ahandle 266 manually pivotable towards stationary handle 264 for clampingof the jaws, an endoscopic portion 268 extending from the handle housing267, and a jaw assembly containing jaws 272 a, 272 b. The endoscopicportion 268 is flexible which enables use in various endoscopicprocedures. The stapler 260 also includes a rotation knob 270 forrotation of the endoscopic portion 268 to rotate the jaws 272 a, 272 b.Power pack 18 is shown fully loaded (inserted) within the handle housing262 and cover 263 closed to seal the power pack 18 from the externalenvironment. As in the embodiment of FIGS. 1-12 , the flag 42 extendingfrom lead screw 36 engages a firing rod within the handle housing 262 toeffect movement of a flexible firing rod extending through flexibleendoscopic portion 268 to fire the staples when the motor of the powerpack 18 is actuated. Power pack 90 having articulation described belowcan also be utilized with stapler 260.

The power pack 18 is also not limited to use with endoscopic linearstaplers, nor is it limited to use with staplers. FIGS. 28A-29Dillustrate two examples of different staplers. As in the endoscopiclinear staplers discussed herein, these staplers can also have a knifebar to cut tissue between the rows of staples applied to the tissue.

By way of example, the power pack 18 can be used with a circular staplerthat applies circular arrays of staples such as shown in FIGS. 28A-28D.Surgical stapling instrument 220 can receive and be powered by the powerpack 18 of the present disclosure. Stapler 220 has a handle 226 manuallypivotable towards stationary handle 264 for clamping of the jaws, anelongated tubular portion 228 extending from the handle housing 222, anda jaw assembly having an anvil (jaw) 232 and a cartridge (jaw) 235containing circular arrays of fasteners (staples). The anvil 232 has aproximal clamping surface 233 and is movable by anvil rod 234 toward thecartridge 235 to clamp tissue between the anvil clamping surface 233 anddistal clamping surface 236 of cartridge 235 by manual movement ofhandle 226 toward stationary handle 224. The stapler 220 also includes arotation knob 230 for rotation of the elongated portion (shaft) 228 torotate the jaws 232, 235. Power pack 18 is shown fully loaded (inserted)within the handle housing 222 and cover 223 is shown closed to seal thepower pack 18 from the external environment. As in the embodiment ofFIGS. 1-12 , the flag 42 extending from lead screw 36 engages a firingrod within the handle housing 222 to effect movement of a firing rodextending through elongated portion 228 to fire the circular arrays ofstaples when the motor of the power pack 18 is actuated. Power pack 90having articulation described below can also be utilized with stapler220.

By way of another example, the power pack can be used with a linearstapler that applies transverse rows of staples in a linear direction,i.e., parallel to the longitudinal axis of the stapler, such as shown inFIGS. 29A-29D. Surgical stapling instrument 240 can receive and bepowered by the power pack 18 of the present disclosure. Stapler 240 hasa handle 246 manually pivotable towards stationary handle 244 forclamping of the jaws, an elongated tubular portion 248 extending fromthe handle housing 242, and a jaw assembly containing an anvil (jaw) 252and a cartridge (jaw) 255 containing linear rows of fasteners (staples)arranged perpendicular to the longitudinal axis of the stapler 240. Theproximal anvil clamping surface 253 of anvil 252 and distal clampingsurface 256 of cartridge 255 are brought into approximation by manualmovement of handle 246 toward stationary handle 244 which advancescartridge 255 toward anvil 252. (Alternatively the anvil could beretracted toward the cartridge). The stapler 240 also includes arotation knob 250 for rotation of the elongated portion (shaft) 248 torotate the elongated portion 248 and jaws 252, 255. Power pack 18 isshown fully loaded (inserted) within the handle housing 242 and cover243 is shown closed to seal the power pack 18 from the externalenvironment. As in the embodiment of FIGS. 1-12 , the flag 42 extendingfrom lead screw 36 engages a firing rod within the handle housing 242 toeffect movement of a firing rod extending through elongated portion 248to fire the staples from cartridge 255 when the motor of the power pack18 is actuated. Power pack 90 having articulation described below canalso be utilized with stapler 240.

The power pack 18 can also be used with single firing instruments thatfire a single staple, clip, tack, etc. into body tissue. Two examples ofsuch instruments are illustrated in FIGS. 31A-31D and FIGS. 34A-34D.Turning first to the instrument 280 of FIGS. 31A-31D, by way of example,surgical clip applying instrument 280 can receive and be powered by thepower pack 18 of the present disclosure. Stapler 280 has a handle 286manually pivotable towards stationary handle 284 for loading a clip intothe jaws, an elongated tubular portion 288 extending from the handlehousing 282, and a pair of pivotable jaws 292 which support a cliptherebetween. Closing of the jaws 292 crimps the clip about tissue. Theclip applier 280 also includes a rotation knob 290 for rotation of theelongated portion (shaft) 288 to rotate the jaws 292. Power pack 18 isshown fully loaded (inserted) within the handle housing 282 and cover283 is shown closed to seal the power pack 18 from the externalenvironment. As in the embodiment of FIGS. 1-12 , the flag 42 extendingfrom lead screw 36 engages a rod within the handle housing 282 operablyconnected to a clip closing mechanism to effect movement of the clipclosing mechanism to close the jaws to apply to tissue a surgical clipsupported by the jaws 292. The power pack 18 can also have a motorpowered drive assembly for advancing the clip into the jaws 292, thedrive assembly engageable with a clip feed mechanism.

Another example of a single firing instrument is illustrated in FIGS.34A-34D and designated generally by reference numeral 340. Instrument340 can receive and be powered by the power pack 18 of the presentdisclosure. Instrument 340 has a handle 346 manually pivotable towardsstationary handle 344 for angling the surgical tack and an elongatedtubular portion 348 extending from the handle housing 342. Tackersupport 345 is pivotable relative to the longitudinal axis by movementof handle 346 which is operably connected to an elongated member whichpivots support 345. The instrument 340 also includes a rotation knob 350for rotation of the elongated portion (shaft) 348. Power pack 18 isshown fully loaded (inserted) within the handle housing 342 and cover343 is shown closed to seal the power pack 18 from the externalenvironment. As in the embodiment of FIGS. 1-12 , the flag 42 extendingfrom lead screw 36 engages a rod within the handle housing 342 operablyconnected to a tack firing mechanism to effect advancement of the tack347 into tissue. The power pack 18 can also be provided with a motorpowered drive assembly to pivot support 345.

In the embodiments of FIGS. 1-12 , a gear mechanism is driven by themotor to rotate the lead screw to advance the drive mechanism to effectfiring of the staples. In the alternate embodiments of FIGS. 24A-27D, abelt drive mechanism is used to effect firing. The belt drive mechanismis contained in the power pack 18 in the same manner as the gearmechanism of the foregoing embodiments, and thus the power pack for thebelt drive would include the housing 19 of the configuration of FIG. 1and loaded in the stapler 1 in the same manner as power pack 18described above. The belt drives of FIGS. 24A-27D are described belowfor use with stapler 1 of FIG. 1A but can be used in the other surgicalstaplers and instruments disclosed wherein which are designed to receivepower pack 18 or power pack 90 for powered actuation.

Turning first to the embodiment of FIGS. 24A-24D, the belt driveassembly (mechanism) includes a motor 148 connected to a planetary gearbox 150 configured to gear down the output of the motor 148 for properdrive speeds for firing staples from jaw 8 a through the tissue intocontact with the anvil of jaw 8 b. The planetary gear box 150 drives alead screw 144 via the drive belt operatively connected to the motorshaft. More specifically, upon rotation of the motor shaft by motor 148,first rotatable disc 152 (also referred to as the first wheel or pulley)is rotated in a first direction, causing movement of belt 156 androtation of second rotatable disc 154 (also referred to as the secondwheel or pulley). Note the two discs 152, 15 are spaced apart and not incontact. Lead screw 144 is operatively connected to disc 154 so thatrotation of disc 154 causes rotation of lead screw 144 in the samedirection. The power pack 18 includes a battery which can berechargeable outside the stapler when the power pack 18 is removed. Themotor 148 is actuated in the various ways described above with regard topower pack 18 of FIG. 3A. A tensioner can be provided such as tensioner158, illustratively in the form of a tension disc or wheel, to apply aforce against the belt 156. In the orientation of FIGS. 24C and 24D, thetensioner 158 is positioned underneath the drive belt 156 and applies anupward tensioning force against the belt 156 in a direction toward discs152, 154. Other types of mechanisms to apply a tensioning force to thebelt are also contemplated for use in the embodiments of FIGS. 24A-27Dif such tensioning of the drive belt 156 is desired.

Connected to the end of lead screw 144 (the end opposite of theconnection to the disc 154) is a drive mechanism 142. The drivemechanism 142, like drive mechanism 40 of FIG. 3A, is configured to movein a linear motion (in an axial direction) along the lead screw 144 inresponse to rotation of the lead screw 144. For example, as in the drivemechanism 40, drive mechanism 142 may include internal threads thatengage external threads of the lead screw 144 and may include slidesengaged in a track that prevent the drive mechanism 142 from rotatingand therefore cause the drive mechanism 142 to move linearly in responseto rotation of the lead screw 144. As shown, the lead screw 144 extendsalongside, slightly spaced from, the motor 148 and gear box 150, i.e.,both the motor 148/gear box 150 and lead screw 144 extendinglongitudinally with the lead screw 144 parallel to the motor 148. Thedrive mechanism 142 extends proximally of the proximal end of the motor148 in the illustrated embodiment.

The drive mechanism 142, like drive mechanism 140 of FIG. 3A, includes afirst output flag or yoke 146 with slot 143 configured to engage astaple firing rod 46 extending longitudinally within the handle 4. Theflag 146 is the same as flag 42 of FIG. 4A and engages the staple firingrod 46 in the same manner as flag 42. Therefore, for brevity, furtherdiscussion of flag 146 and it engagement with firing rod 46 is notprovided as the structure and function of flag 42, and alternativefiring rod engagement features, are fully applicable to flag 146 ofFIGS. 24A-24D. In brief, as the motor 148 generates rotational motion ofthe lead screw 144 through the drive belt, the drive mechanism 144 movesin linear motion along the lead screw 144 to effect linear movement ofthe firing rod 46 which advances the staple driving mechanism to advance(fire) the staples out from jaw 8 b through tissue and into contact withthe anvil in jaw 8 a.

FIGS. 25A-25D illustrate an alternate embodiment of a belt drivemechanism. Belt drive mechanism (assembly) 160 is identical to beltdrive 140 except for the different sized discs (wheels). That is,assembly 160 has a motor 168 connected to a planetary gear box 170configured to gear down the output of the motor 168. The planetary gearbox 170 drives a lead screw 164 through the belt drive operativelyconnected to the motor shaft. Upon rotation of the motor shaft by motor168, first disc 172 is rotated in a first direction, causing movement ofbelt 176 and rotation of second disc 174 in the same direction. Leadscrew 164 is operatively connected to disc 174 so that rotation of disc174 causes rotation of lead screw 164 in the same direction. A tensioner178 like tensioner 158 can be provided to apply tension to the belt 176.The drive mechanism 162, like drive mechanism 40 of FIG. 3A, includes afirst output flag or yoke 166 with slot 163 configured to engage astaple firing rod 46 in the same manner as flag 42. Rotation of themotor shaft generates rotational motion of the lead screw 164 throughthe drive belt, causing the drive mechanism 162 to move in linear motionalong the lead screw 164 to effect linear movement of the firing rod 46which advances the staple driving mechanism to advance (fire) thestaples out from jaw 8 b through tissue and into contact with the anvilin jaw 8 a.

The belt drive 160 differs from belt drive 140 of FIG. 24A in thatsecond disc 174 which is operatively connected to lead screw 164 islarger in diameter than first disc 172. Consequently, instead ofproviding a one to one ratio of the discs as in discs 154 and 152 ofFIG. 24A, a greater ratio of disc 174 to disc 172 is provided whichvaries the output of motor 168. That is, the rotational output of leadscrew 164 is less than the rotational output of the motor shaft due tothe differing degree of rotation of discs 174, 178 due to the varyingsizes. In all other respects, mechanism 160 is identical to mechanism140.

FIGS. 26A-26D illustrate an alternate embodiment of a belt drivemechanism. Belt drive mechanism (assembly) 180 is identical to beltdrive 140 of FIG. 24A except for the configuration of the drive belt anddiscs. That is, assembly 180 has a motor 188 connected to a planetarygear box 190 configured to gear down the output of the motor 188. Theplanetary gear box 190 drives a lead screw 184 through the belt driveoperatively connected to the motor shaft. Upon rotation of the motorshaft by motor 188, first disc (wheel or pulley) 192 is rotated in afirst direction, causing movement of belt 196 and rotation of seconddisc (wheel or pulley) 194. Lead screw 184 is operatively connected todisc 194 so that rotation of disc 194 causes rotation of lead screw 184in the same direction. A tensioner 198 like tensioner 158 can beprovided to apply tension to the belt 196. The drive mechanism 182, likedrive mechanism 140 of FIG. 3A, includes a first output flag or yoke 186with slot 183 configured to engage a staple firing rod 46 in the samemanner as flag 42. Rotation of the motor shaft generates rotationalmotion of the lead screw 184 through the drive belt, causing the drivemechanism 182 to move in linear motion along the lead screw 184 toeffect linear movement of the firing rod 46 which advances the stapledriving mechanism to advance (fire) the staples out from jaw 8 b throughtissue and into contact with the anvil in jaw 8 a.

The belt drive 180 differs from belt drive 140 of FIG. 24A in that discs192, 194 have teeth to engage ribs or treads on belt 196. As shown, thetoothed discs 192, 194 are spaced apart so their teeth/projections donot intermesh—the teeth of disc 192 engage belt 196 and the teeth ofdisc 194 engage belt 196. Rotation of disc 192 moves drive belt 194 inthe same direction due to its engagement with the teeth, which causesrotation of toothed disc 194 in the same direction due to engagementwith its teeth to rotate lead screw 184. In all other respects,mechanism 180 is identical to mechanism 140.

FIGS. 27A-27E illustrate an alternate embodiment of a belt drivemechanism. Belt drive mechanism (assembly) 200 is identical to beltdrive 180 except for the different sized discs. That is, assembly 200has a motor 208 connected to a planetary gear box 210 configured to geardown the output of the motor 208. The planetary gear box 210 drives alead screw 204 through the belt drive operatively connected to the motorshaft. Upon rotation of the motor shaft by motor 208, first disc (wheelor pulley) 212 is rotated in a first direction, causing movement of belt216 and rotation of second disc (wheel or pulley) 214. Lead screw 204 isoperatively connected to disc 214 so that rotation of disc 214 causesrotation of lead screw 204 in the same direction. A tensioner 218 liketensioner 198 can be provided to apply tension to the belt 216. Thedrive mechanism 202, like drive mechanism 140 of FIG. 3A, includes afirst output flag or yoke 206 with slot 203 configured to engage astaple firing rod 46 in the same manner as flag 42. Rotation of themotor shaft generates rotational motion of the lead screw 204 throughthe drive belt, causing the drive mechanism 202 to move in linear motionalong the lead screw 204 to effect linear movement of the firing rod 46which advances the staple driving mechanism to advance (fire) thestaples out from jaw 8 b through tissue and into contact with the anvilin jaw 8 a.

The belt drive 200 differs from belt drive 180 of FIG. 24A in thatsecond toothed disc 214 which is operatively connected to lead screw 204is larger in diameter than first toothed disc 172. Consequently, insteadof providing a one to one ratio of the discs as in discs 194 and 192, agreater ratio of disc 214 to disc 212 is provided which varies theoutput of motor 208. That is, the rotational output of lead screw 204 isless than the rotational output of the motor shaft due to the differingdegree of rotation of discs 214, 212 due to the varying sizes. In allother respects, mechanism 200 is identical to mechanism 180.

It should be appreciated that the foregoing belt drive mechanisms can beused as an alternative to the gear mechanism in power pack 18 as well asan alternative to one or both of the gear mechanisms of power pack 90discussed below.

In the foregoing embodiments, the power pack 18 was described forpowering staple firing. In an alternate embodiment, the power pack caninclude a drive mechanism for effecting articulation. This motor poweredarticulation can be in addition to the motor powered staple firing, oralternatively, the power pack can be used solely for poweredarticulation. The embodiment of FIGS. 14A-23B illustrate a surgicalstapler and power pack which powers both staple firing and articulation.If only for articulation, the power pack described below (power pack 90)would not include the gear mechanism engageable with the firing rod 46for staple firing.

With initial reference to FIGS. 14A-14C, surgical stapler 61 isidentical to surgical stapler 1 of FIG. 1A except for the power packmounted in the stapler 61 and the articulation rod in the stapler 61which is engaged by the power pack. Thus, like stapler 1, stapler 61 hasa handle assembly 63, an endoscopic portion 66 extending distallytherefrom and a pair of jaws 68 a, 68 b, (collectively “jaws 68”) withat least one of the jaws movable relative to the other jaw, e.g., jaw 68b containing the staples (fasteners) movable toward stationary jaw 68 acontaining the anvil pockets. Handle 72 like handle 14 of stapler 1 ispivotable toward stationary handle 70 to approximate jaws 68 a, 68 b toclamp tissue between the closed jaws 68 a, 68 b. Handle assembly 63includes a housing 64 and cover 62 which is identical to cover 22 ofstapler 1, i.e., pivotably mounted to the housing 64 to move from aclosed to an open position for top loading (or alternatively otherdirectional loading) a power pack into the compartment within thehousing 64. The compartment, like compartment 25 described above,retains the power pack and can include guiding structure for alignmentof the power pack similar to guiding structure 28 described above toreceive guides 90 a, 90 b of power pack 90. Stapler 61 also includes arotation knob 74 which functions in the same manner as rotation knob 12of stapler 1 described above to rotate tubular portion (shaft) 66. Thejaw assembly, i.e., jaws 68 a, 68 b, articulate about joint 69 to movethe jaws 68 a, 68 b to angular positions with respect to thelongitudinal axis of stapler 61.

The power pack in the embodiment of FIGS. 14A-23B is designated byreference numeral 90 and has a motor assembly and drive mechanism forfiring staples which is identical to that of the power pack 18 of FIG.3A. However, power pack 90 differs from power pack 18 in that itadditionally has a motor assembly and drive mechanism for articulatingthe jaws. The addition of the articulation assembly can be appreciatedby a comparison of the cross-sectional view of FIG. 4H, which onlyeffects firing of the fasteners (staplers), and the cross-sectional viewof FIG. 15F which effects firing of fasteners and articulation of thejaw assembly.

More specifically, with reference to FIGS. 15A-15F and 18B, the poweredstaple firing assembly like the firing assembly of power pack 18 of FIG.4H, includes a motor 83 connected to a planetary gear box 85 configuredto gear down the output of the motor in the same manner as motor 32 andgear box 34 of power pack 18. The planetary gear box 85 drives a leadscrew 86 through one or more gears operatively connected to the motorshaft. More specifically, upon rotation of the motor shaft by the motor83 in a first direction, gear 81 is rotated in the same first direction,causing rotation of the gear 84 in a second opposite direction due tothe intermeshed teeth of gears 81 and 84. Lead screw 86 is operativelyconnected to gear 84 so that rotation of gear 84 causes rotation of leadscrew 86 in the same direction. The power pack 18 includes a battery 33which can be rechargeable outside the stapler when the power pack 18 isremoved. The power pack 90 in some embodiments can include a powerswitch which is activated, i.e., turned on, by the clinician to startthe motor and effect staple firing. In other embodiments, the motor canautomatically turn on when fully loaded or upon actuation of anothercontrol on the stapler housing 4.

Connected to the end of lead screw 86 (the end opposite the connectionto the gear 84) is a drive mechanism 80 which is configured to move in alinear motion (in an axial direction) along the lead screw 86 inresponse to rotation of the lead screw 86. Drive mechanism 80 includes aflag or yoke 82 identical to yoke 42 of power pack 18 discussed above,which engages flange or boss 76 of firing rod 75 within housing 64 ofstapler 61. The connection of the flag 82 to the firing rod 76, themotor and gear mechanism, and the drive mechanism 80 of power pack 90are the same as the power pack 18 and therefore the aforedescribedfunctions and features/components of power pack 18 for staple firing arefully applicable to the function and features/components of power pack90 for staple firing so for brevity are not fully repeated herein. Itshould also be appreciated that the alternative mechanisms for motorpowered stapled firing, such as the various belt drive mechanismsdiscussed above and/or illustrated in the Figures, can also be used inthe power pack 90 to effect staple firing. Additionally, the varioussensors discussed above with regard to sensing the firing stroke canalso be provided in power pack 90 for the same uses.

Power pack 90 also has an articulation assembly, shown in detail inFIGS. 22A-22D. The articulation assembly includes a powering assemblyincluding a motor 96 connected to a planetary gear box 93 configured togear down the output of the motor 96. The planetary gear box 93 drives alead screw 98 through gears 91, 92 operatively connected to the motorshaft. More specifically, upon rotation of the motor shaft by motor 96in a first direction, gear 91 is rotated in the same first direction,causing rotation of the gear 92 in a second opposite direction due tothe intermeshed teeth of gears 92 and 91. Lead screw 98 is operativelyconnected to gear 92 so that rotation of gear 92 causes rotation of leadscrew 98 in the same direction. The power pack 90 in some embodimentscan include a power switch which is activated, i.e., turned on, by theclinician to start the motor and effect articulation.

Connected to the end of lead screw 98 (the end opposite the connectionto the gear 92) is a drive mechanism 95 configured to move in a linearmotion (in an axial direction) along the lead screw 98 in response torotation of the lead screw 98. For example, the drive mechanism 95, likedrive mechanisms 40 and 80 described above, may include internal threadsthat engage external threads of the lead screw 98 and may include slidesengaged in a track that prevent the drive mechanism 95 from rotating andtherefore cause the drive mechanism 95 to move linearly (axially) inresponse to rotation of the lead screw 98. As depicted, the power pack90 has a compact configuration as the lead screw 98 extends alongside,slightly spaced from, the motor 96 and gear box 93, i.e., both the motor96/gear box 93 and lead screw 98 extending longitudinally with the leadscrew 98 parallel to the motor 96. The drive mechanism 95 is connectedto a proximal end of lead screw 98. The drive mechanism 95 has anarticulation rod engagement feature in the form of a flange or yoke 94extending therefrom having legs 99 a and a recess 99 b to engage anarticulation rod 79 within the housing 63. In the illustrated embodiment(see e.g., FIGS. 15B and 22C), the articulation rod 79 includes a flange78 which is engageable by the flag 94. The output flag 94 can engage thebossed end 78 of the articulation tube 79 in substantially the samemanner as the output flag 42 engages the bossed end 44 of the firing rod46 as discussed above.

The articulation assembly of the power pack 90 is oriented in theopposite direction from the staple firing assembly to minimize the spacerequired in the power pack 90, thereby providing the power pack with acompact configuration. As can be appreciated by reference to FIGS. 15Aand 15F, the drive assembly 80 and associated flag 82 are at a proximalend of the assembly for firing staples with the lead screw 86 extendingdistally toward the gears 81, 84. The driving assembly 95 withassociated flag 94 of the assembly for articulation are at a distal endwith the lead screw 98 extending proximally toward gears 91, 92. Also ascan be appreciated by reference to the orientation of FIGS. 15A and 15F,the articulation assembly is above (closer to the cover 22) than thefiring assembly, and the articulation assembly in the illustratedembodiment is positioned axially proximal of gears 81, 84 and axiallydistal of drive mechanism 80, radially spaced from lead screw 86.

The power pack 90, like power pack 18 can have features/structure toconstrain the motors 84 and 96. In the embodiment of FIG. 15D, suchfeature is in the form of proximal rails 97 a and distal rails 97 bspaced apart axially within the housing of the power pack 90. Gear box93 is seated within proximal rails 97 a and motor 96 is seated withindistal rails 97 b, the rails 97 a, 97 b retaining the motor andpreventing axial and rotational movement within the housing of powerpack 90. Bearing or bushings 98 a, 98 b can also be provided toconstrain the lead screw 98 at opposing ends, while allowing rotationthereof, thereby also constraining the motor. Other features canadditionally or alternatively be provided to restrain the motor fromaxial movement while allowing rotation of the lead screw.

The power pack 90 can include guides, e.g., projections 90 a, 90 b,either axially aligned or axially offset, similar to guides 28 of powerpack 18 for alignment with guiding structure in the compartment ofstapler 61. This can prevent misloading of the power pack.

In use, with the cover 62 of stapler 61 in the open position, power pack90 is loaded into the compartment of the handle housing 63. The cover 62is closed to seal the power pack 90 from contaminants in same manner ascover 22 of stapler 1. Upon loading of the power pack 90, flag 82 of thedrive mechanism 80 of the staple firing assembly engages flange 76 offiring rod 75 and flag 94 of drive mechanism 95 of the articulationassembly engages flange or bossed end 78 of articulation rod 79.Actuation of the motor 96 effects linear motion of the flag 94 whichmoves the articulation rod 79 linearly (axially). The articulation rod79 is either directly coupled to the joint 69, or coupled to anothermember or multiple members which are coupled to the joint 69. When movedlinearly, the articulation rod 79 effects movement of the jaws 68A, 68 bof the stapler 61 to angular positions with respect to the longitudinalaxis of the stapler 61. Note the articulation drive assembly operates ina similar manner as the firing drive assembly of power pack 18 in thatwhen the power pack 90 is secured to the tube 79 by the second outputflag 94, linear motion generated at the second output flag 94 istransferred to linear motion of the tube 79.

Actuation of the motor 83 effects linear motion of the flag 82 whichmoves the firing rod 75 linearly (axially). The firing rod 75 eitherextends through the elongated portion 66 for engagement of the firingmechanism in the jaw 68 b or is coupled to another elongatedcomponent(s) extending through the endoscopic portion 66 to engage thefiring mechanism in the jaw 68 b. Note that the articulation rod or tube79 can be configured to receive the firing rod 75 so that the firing rod75 can move within the tube 79 to effect firing and the articulation rod79 can slide linearly over the firing rod to effect articulation.

After use, the cover 62 can be opened and the power pack 90 removed andcharged while the handle assembly 63 (and stapler 61) is sterilized ordisposed of if the stapler is a disposable instrument. The power pack90, like power pack 18 described above, may be reused without requiringsterilization by being inserted into the receptacle of thenow-sterilized handle assembly 63 or a different sterile handleassembly. Thus, the removable power pack 90, like power pack 18, doesnot need to be subjected to the sterilization process and, therefore,contact between the harsh temperatures and/or chemicals of thesterilization process is advantageously avoided.

One or more seals are utilized for sealing power pack 18 and power pack90 within the handle assembly 2 or 63 so that the power pack remainssterile and is not exposed to bodily fluids during surgical procedures.For example, as discussed above, in the stapler 1 of FIG. 1 , the topseal 24 is positioned at the interface between the cover 22 and thehousing 4 of the handle assembly 2 where the cover 22 closes for sealingthe opening into the receptacle 20 and, therefore, power pack 18 fromthe environment when positioned therein. Similarly, in the stapler 61 ofFIG. 14A, the top seal is positioned at the interface between the cover62 and the housing 64 of the handle assembly 63 wherein the cover 62closes for sealing the opening into the receptacle and, therefore, powerpack from the environment when positioned therein. As shown in FIGS.21A-21C, further seals can be provided to further seal the receptacleand thus the power pack. An 56 is placed around the articulation rod 79to seal the space around the rod 79. A flexible trigger seal 58surrounds the lever 72 for sealing the internal components of the handleassembly 63 throughout the range of positions of the movable lever 72.Thus, all of the openings into the receptacle of the handle assembly 63are sealed from the external environment. The O-ring seal 56 and triggerseal 58 can also be used in stapler 1 so the openings into thereceptacle 20 of handle assembly 2 are sealed from the externalenvironment. Elastomeric seal 59 a seals cover 62 from U-channel 59within the handle which supports the power pack 90. Additional seals canbe provided to prevent flow of body fluid through the endoscopic portion66 (and endoscopic portion 6). Other types of seals and seals indifferent locations are also contemplated.

FIGS. 35-37C illustrate alternate embodiments of the power pack having aremovable battery pack. Each of the power packs (power trains) 406, 420and 430 in the embodiments of FIGS. 35-37C can have a motor assembly anddrive mechanism for firing staples which is identical to that of thepower pack 18 of FIG. 3A or alternatively can have a motor and drivemechanism for firing staples and additionally a motor assembly and drivemechanism for articulating the jaws as in power pack 90 of FIG. 14Adescribed above. The surgical staplers for receiving power packs 406,420 or 430 are the same as the surgical stapler 1 (except for thecompartment and cover) so that it has been labeled with like referencenumerals. The power packs 406, 420 and 430 could also be used with theother surgical staplers described herein or with other surgicalinstruments such as those described herein. Therefore, furtherdiscussion of the surgical staplers is not provided herein as thedescription of the stapler 1 components (e.g., shaft 6, jaws 8 a, 8 b,handle 12, etc.) and its functions, as well the description of otherstaplers, are fully applicable to the stapler receiving power packs 406,420 or 430.

Turning first to the embodiment of FIG. 35 , the power pack 406 has anupper surface 412 having a cavity 410 to slidably receive card-likebattery pack 408. Battery pack 408 is slid into the cavity and engages acontact within the housing to enable actuation of the motor to power thedrive mechanism within the power pack 406 to effect staple firing and/orjaw articulation in the same manner as described above (via engagementby the flag or yoke). Power pack 406 is placed into the cavity 404 ofhousing 402 in a similar manner as described above, e.g., top loadedinto the compartment, and the hinged cover 407 is closed to seal thepower pack 406 from the external environment. Cover 407 differs fromcover 22 in that it includes a spring loaded latch 409 received in latchcavity 405 of housing 402 to retain the cover 407 in the closedposition. The latch 409 is released by pressing latch 409 to disengagethe latch 409 so the cover 407 can be opened to access the power pack406. Raised surface (tab) 414 on one or both sides of the power pack 406aligns with a recess in the compartment 404 for alignment of the powerpack 406 during insertion.

In use, the battery pack 408 can be aseptically preloaded in the powerpack 406, either by a user or packaged with the battery pack 408preloaded, and the power pack 406 is aseptically preloaded into thesurgical instrument. During a surgical procedure, in the event of abattery failure, the cover 407 can be opened and the power pack 406 canbe removed intraoperatively from compartment 404, the battery pack 408removed from cavity 410, a new (second) charged battery (battery pack)aseptically placed in cavity 410 and the power pack 406 with thereplacement battery pack reloaded into compartment 404. In analternative use, during a surgical procedure, in the event of a batteryfailure, the cover 407 can be opened and with the power pack 406remaining in compartment 404, the battery pack 408 is removed fromcavity 410 of the power pack 406 and a new (second) charged replacementbattery (battery pack) aseptically placed in cavity 408 while the powerpack 406 remains loaded (positioned) within the compartment 404 of thesurgical instrument.

In the alternate embodiment of FIG. 36 , the stapler 1 is the same as inFIG. 35 , the difference being the power pack and battery pack. Morespecifically, power pack 420 has an outer upper surface 422 extendingproximally from wall 428, on which the battery pack 424 is mounted. Wall425 of battery pack 424 can be placed in abutment with wall 428, and thepower pack 420 and battery pack 424 can be dimensioned so that thebattery pack 424 becomes part of the outer contour of the power pack420, e.g., the upper surface 427 of the power pack can be substantiallyflush with the upper surface 429 of the power pack 420, although inalternate embodiments the upper surface can be below or above the uppersurface 429. Power pack 422 can have an alignment tab 426 on one or bothsides to aid insertion/alignment. The battery pack 424 can include anengagement feature 420 interacting with the power pack/to secure thebattery pack 424 on the power pack 420.

In use, as with power pack 406 described above, the battery pack 420 canbe preloaded, i.e., pre-mounted, onto the power pack 406 (by the user orprepackaged) and can be removed and replaced with another (second)charged battery (battery pack) during a surgical procedure by firstremoving the power pack 406 from the compartment 404 of stapler 1 oralternatively the battery pack 420 can be removed from the power pack406 and replaced by another charged battery pack while the power pack406 remains in the compartment 404.

In the alternate embodiment of FIGS. 37A-37C, the battery pack 440 ismounted into a cavity (receptacle) in the power pack 430. Note thestapler 1 of FIGS. 37A-37C is the same as in FIG. 35 , the differencebeing the power pack and battery pack. Power pack 430 has a cavity 432extending along its length dimensioned to receive battery pack 440. Thepower pack 430 and battery pack 440 can be dimensioned so that thebattery pack 440 becomes part of the outer contour of the power pack430. Irregular gripping surface or tab 442 on side wall 443 of batterypack 440 is received in cutout 432 on the side wall of power pack 430.The gripping surface can be grasped by the user to facilitate removal asthe battery pack 440 is removed from the power pack 430. In someembodiments, a gripping surface or tab like surface 442 can also beprovided on the opposing side wall (received in another cavity likecavity 432 positioned on the opposing side) for facilitating graspingboth sides of the battery pack 440 for removal from the power pack.

In the loaded position, the battery pack can protrude slightly above theplane of the top edges 404 a of the compartment 402 as shown in FIG. 37Cor alternatively can be flush or below the plane of the compartmentedges 404 a. In any case, the power pack and mounted battery pack 440are placed sufficiently within the compartment 402 so that the cover 407can be completely closed to seal the power pack 430 and battery pack 440from the external environment.

In use, the battery pack 440 can be preloaded in the power pack 430,either by a user or packaged with the battery pack 440 preloaded. Duringa surgical procedure, in the event of a battery failure, the cover 407can be opened, power pack 430 removed from compartment 404, the batterypack 440 removed from cavity 434, a new (second) charged battery(battery pack) aseptically placed in cavity 434 and the power pack 440with a replacement battery pack reloaded into compartment 404. In analternative use, during a surgical procedure, in the event of a batteryfailure, the cover 407 can be opened and with the power pack 430remaining in compartment 404, the battery pack 440 is removed fromcavity 434 of the power pack 440 and a new (second) charged battery(battery pack) aseptically placed in cavity 434 while the power pack 430remains loaded (positioned) within the compartment 404.

Note the battery packs disclosed herein can include custom cells oralternatively off the shelf batteries. The use of the term battery packas used herein encompasses different types of batteries and differenthousings for the batteries which are mounted on or inserted either fullyor partially into the power pack housing (which contains the powertraintherein) to operatively connect with the motor in the power pack.

The battery packs can be retained, e.g., locked, in or on the power packhousing in various ways such as a latch, spring loaded engagement,frictional engagement, interlocking tabs, etc., and such mountings canalso include a release button for disengaging/removing the battery packfrom the power pack.

As noted above, the power pack 90 can be used with the other staplersdisclosed herein, e.g. circular staplers, linear staplers, as well asother instruments wherein two powered functions are desired. The firstmotor assembly can effect linear motion of a first elongated member toeffect a first function of the stapler, e.g., clamping, articulation,firing, and the second motor assembly can effect linear motion of asecond elongated member to effect a second different function of thestapler, e.g., clamping, articulation, firing. In the embodiment of FIG.14A, one function is articulation and another function is staple firing.Note the power pack 90 can also be used with surgical instruments otherthan surgical staplers such as those illustrated in FIGS. 33A and 34A.

FIGS. 38-41 illustrate an alternate embodiment of the staplinginstrument having an encoder with switching devices to effectarticulation and firing. Operation of the instrument is illustratedschematically in the concept diagrams of FIGS. 38-40 .

Initially, with reference to FIG. 38 , the powertrain (also referred toherein as the power pack) is inserted into a homing cradle. Thepowertrain has an external homing switch engaged with the homing cradle.The replaceable battery can be inserted into the cradle either before orafter the battery is loaded into the powertrain. A DC to DC convertercan be provided to boost battery voltage from for example 7.6V to 18V. Asafety (thermosensor) can be provided on the battery pack to preventoverheating. For example, a battery life indicator (e.g., a gas gauge)can be provided as part of a battery management system to preventbattery overheating. A circuit board in the charger monitors thethermosensor so if the temperature exceeds a predetermined threshold, itautomatically shuts down the charge to the battery. Indicator lightsproviding battery status can be provided. Within the homing cradle, theenable switch is allowed. The powertrain powers up and the unit goesthrough a homing sequence so that the articulation motor and the firingmotor are both in the home position. A screen can be provided on one ormore of the powertrain or the cradle to indicate the articulation andfiring are in the home positions and the system is ready for use(enabled), i.e., ready for loading into the surgical instrumentcompartment for powering the surgical functions of the instrument. Theswitches are enabled within the homing cradle but cannot be actuatedwithin the cradle. A screen/window can also be provided on theinstrument, e.g., instrument housing, to indicate the home position.

FIG. 39 illustrates schematically how the surgical functions areenabled/disabled based on the position of the instrument jaws. This isachieved through software in the powertrain (power pack). With thepowertrain loaded in the compartment, if the instrument jaws are open,the firing mechanism, i.e., the firing switch, is disabled. This ensuresthat the staples cannot be advanced from the staple receiving jaw andthe knife bar cannot be advanced distally unless the jaws are properlyclamped on tissue. In the open position of the instrument jaws, thearticulation mechanism, i.e., the articulation switch, is enabled sothat the cartridge and anvil jaw assemblies can be articulated byactuation of the articulation motor to various angles with respect tothe longitudinal axis of the surgical instrument.

With continued reference to the diagram of FIG. 39 , with the powertrainloaded in the compartment, if the instrument jaws are moved to theclosed (tissue clamping position), the firing mechanism, i.e., thefiring switch, is enabled. This enables the firing motor to be actuatedso the firing mechanism and cutting blade can be advanced distally tofire the staples and cut tissue clamped between the jaws. In the closedposition of the instrument jaws, the articulation mechanism, i.e., thearticulation switch, is disabled so that the cartridge and anvil jawassemblies cannot be articulated.

The foregoing is shown in the stapler of FIGS. 41A and 41B, wherein inthe open position of the jaws (FIG. 41A), the manually actuated clampinghandle 514 is in the open position with the engagement surface 510spaced from the switch 512. When the clamping handle 514 is moved to theclosed position (FIG. 41B), the engagement surface 510 comes intocontact with the switch 512 to complete the circuit for activation ofthe firing mode. In this clamped position, the firing button 518 can beactuated to effect staple firing. With the engagement surface 510 spacedfrom the switch 512, the circuit is open such that actuation of thefiring button 518 will not actuate the motor and thus not initiatefiring. Alternatively, the switch can be in the “closed position” inboth handle positions with the software detecting the clamped positionof the handle.

The steps for loading the powertrain and using the instrument will nowbe described in conjunction with the flow chart of FIGS. 40A-40C. Thepowertrain is inserted into the homing cradle followed by insertion ofthe battery into the homing cradle. This moves the articulation andfiring motors into the home position. If the screen indicates completionof the homing sequence, i.e., ready for use, the powertrain and chargedbattery are removed from the cradle and placed into the compartment ofthe instrument housing as described above with respect to the otherstaplers. Once the powertrain is properly seated in the compartment, thecompartment cover can be closed which then enables subsequent actuationof the switches. If not properly seated, the switches are not enabled.In some embodiments, as described below, closing of the coverautomatically activates an enable switch.

To use the stapler, the clamping handle is closed to move the jaws tothe closed position for insertion through the trocar. Once inserted, ifarticulation is desired, the handle is unclamped to move the jaws to theopen position and the articulation switch, e.g., a rocker switch orother switches preferably accessible on either side of the instrument,is pivoted to move the jaws from the 0 position to the left or right.The encoder via a motor count detects the articulated position of thejaws which in some embodiments can be visually displayed on aninstrument or power pack screen. After reaching the articulated positionof the jaws, tracked via the motor count, the articulation switch isreleased to maintain the jaws in this position. In some embodiments adouble pump articulation switch can be utilized to bring articulationback to zero automatically.

Next, the jaws are clamped via the manually actuated handle, whichenables activation of the firing mode. With the jaws closed, the firingswitch is actuated, to advance the firing rod and knife bar to applystaples and cut tissue. A motor count tracks the position of the firingrod. That is, the motor encoder detects motor location within a fullstroke, i.e., informs what portion of the cycle (revolutions) of thecomplete cycle the firing mechanism is in along the firing stroke. Thecount correlates to the amount of spins of the driveshaft, effectivelycontrolling the distance of the drive mechanism, e.g., collar. Thenumber of revolutions is tied into a predetermined (selected) speed anda predetermined time. The motor speed can be automatically adjustedduring use. Note as the motor operates, if there is a spike in amperage,the central processing unit will slow down the motor rpm, and the timecycle will be adjusted accordingly, along with the encoder detection ofthe full stroke.

In some embodiments, to effect firing, the firing trigger needs to bepressed a first time as a pre-actuation mode and then pressed a secondtime to advance the firing rod and knife bar. After application ofstaples, the firing rod and knife bar are retracted to the homeposition. The articulation switch is then actuated to return thearticulation motor and thus the jaws to the home position. The jaws areclosed by the clamping handle and the instrument is removed from thepatient's body through the trocar. Note an abort switch can be providedto reverse motor rotation to retract the firing mechanism and knife barduring the procedure.

After removal of the instrument, the jaws are open and the spentcartridge is removed. If additional staples are required a freshcartridge is loaded into the cartridge receiving jaws and the instrumentjaws are closed and the instrument is inserted through the trocar(returning to block 7 of the diagram of FIG. 40 —“manually pull handleto clamp jaws and insert through trocar.”)

As noted above, in some embodiments, a switch is located on the powerpack which is actuated by the instrument cover when the cover is closed.This is shown in FIGS. 77-82B. Instrument 900, like instrument 61 ofFIG. 14A described above, has an elongated member 902, a pair of jaws907, 905 at a distal portion and rotation knob 914. Pivotable handle 924is movable toward stationary handle 922 to close the jaws for clampingonto tissue. A clamp release button 926 releases the clamp lever to open(unclamp) the jaws, Pivotable cover 912 has a projection or boss 934extending at a proximal region which engages activation (power enable)switch 932 on the power module (power pack) 950 when the cover 912 ismoved from its open position of FIG. 77 to the closed position. Thepower module 950 can be the same as power pack 700 discussed below orany of the other power packs disclosed herein. In this manner, when themotors within the power pack cannot be activated unless the cover 912 isin the closed position. Power pack 950 includes a screen 952 like screen704 disclosed herein. A pair of articulation buttons/switches 930,symmetrical about the axis, are disposed on each side of the instrumenthousing 920 to articulate the jaws 905, 907 in either direction, e.g.,button 905 articulates the jaws to the left and the button on theopposing side (not shown) articulates the jaws to the right. Inalternate embodiments, the opposite buttons can articulate the jaws toleft and right. Once the cover is closed and boss 934 engages the powerenable switch 932, the firing mechanism can be activated via switch 928which in communication with the motor operatively connected to the drivemechanism within the power pack. The electromechanical switch 934 ismounted to PCB board which is fixed within the power pack whichcommunicates with the CPU within the power pack.

The cover can have a seal about its periphery and/or a seal around theperiphery of the opening to the compartment can be provided, asdiscussed above, to seal the power pack within the compartment toprevent entry of contaminants.

Below is a chart summarizing the safety mechanisms of the surgicalinstrument in accordance with some embodiments:

Pre-loading of power Can't activate switch when powertrain in cradletrain into instrument Thermosensor in battery pack monitored byelectronics in charger to shut down charger if overheating Viewablescreen indicates ready/not ready condition of powertrain Can't activateswitch if powertrain not properly loaded and instrument compartmentcover not fully closed Loading into instrument prevented if firing andarticulation not in home position Once powertrain loaded Opening of jawsbreaks circuit to disable firing mode Closing of jaws disablesarticulation mode Cant actuate firing switch if articulation switchactivated Can't actuate articulation switch if firing button activatedEncoder following error if resistance in firing Encoder detects properfunctioning of motor Encoder detects position and completion of firingstroke via motor count Encoder detects articulated jaw position viamotor count Fire button needs to be depressed first as initial stepbefore firing Copycat position so can resume where left off if powerpack replaced Firing abort button to cease advancement of firing rod andretract to home position Removal of Powertrain Can't remove powertrainif articulation driver not in home position Can't remove powertrain ifstaple driver not in home position

FIGS. 68-76C illustrate two embodiments utilizing an encoder to measureeither rotational movement of the ball screw (FIGS. 68-73 ) or linearmovement of the collar/drive mechanism (FIGS. 74-76B). This provides afailsafe if the motor loses communication with the CPU.

Turning first to FIG. 68 , the deployment screw 818 has a collar 830extending therefrom which functions like collar 94 of the deploymentscrew of FIGS. 22A-22D in that it forms an engagement member forengaging and advancing the firing rod (firing mechanism) in the housingof the surgical stapler. This collar configuration is similar to that ofcollar 756 of FIG. 59A of application Ser. No. 16/792,110, filed May 15,2020, the entire contents of which are incorporated herein by reference.

Deployment screw 818 differs from these deployment screws in that itsupports an electromechanical encoder 810. More particularly, theencoder 810 is mounted to encoder holder 812 which has a post 813inserted into opening 826 at a proximal (back) end of screw 818. Otherways to mount the encoder to the screw are also contemplated. Code wheel814 is mounted in opening 816 a of proximal chassis 816. When the motoris actuated to rotate the deployment screw 818 as described herein toadvance the collar 756 and firing mechanism, the static (fixed) codewheel 814 reads the discrete positions of the encoder and sends a signalto the CPU within the power pack indicative of such reading/position.Such rotation count determines the location of the firing mechanism andthus the location of the I-beam firing the staples from the cartridge.Note the number of discrete positions can vary and in some embodimentsthere are 64 discrete positions.

In the alternate embodiment of FIGS. 74-76B, encoder 846 is fixablyattached to collar 846 of deployment screw 848. (Deployment screw 848and collar 846 are otherwise the same as screw 818 and collar 830). Asthe collar 846 moves axially distally when the deployment screw isactuated by the motor as described in the embodiments above, the positonof the collar 846 is detected by scale 850. Scale 850 is attached to thechassis 856 of the power pack housing, and runs along the length of thestroke. The detected axial position of the encoder is sent to the PCBwithin the power pack for determination of firing mechanism location.Note in this embodiment, the encoder 846 us positioned in an indentationat a proximal end of the collar 852 adjacent nut 854, but canalternatively be mounted to the collar in other ways/locations.

Note an encoder similar to that of FIG. 68-73 or 74-76B can also beutilized with the articulation screw to determine the positions of thearticulation mechanism and thus the articulation angle of the jaws. Theencoder could be mounted for example to the articulation screw orcollar.

A screen can be provided on the top of the powertrain to indicate thefiring, clamping and/or articulation modes/positions. The screen can bevisible through a clear window in the housing of the instrument. Anexample of the screen is shown in FIGS. 55 and 57A wherein screen 704 ison a proximal portion of the housing 706 of power pack 700. The screenin this embodiment angles toward the user. It is covered when instrumentcompartment cover 702 is closed, and cover 702 has a transparent portionor window (such as window 913 of cover 912 of FIG. 79 ) so that thescreen 704 is visible when the cover 702 is closed. As can beappreciated, the screen can be provided in other positions and portionsof the power pack 700. The screen 704 can show various features andparameters via numeric designations light or other indicators. Forexample, the screen can show one or more of firing position,articulation position (degree of articulation), the type (staple sizeand length) of cartridge selected, battery life, clamping position,tissue range, confirmation of home positon of articulation mechanismand/or firing mechanism when loaded and/or when ready for removal fromthe instrument compartment, confirmation that the cover is in the fullyclosed position, and/or other conditions of the motor or othercomponents of power pack or instrument.

In alternate embodiments of the present invention, the surgicalinstruments have features to aid staple size selection. Theseinstruments can also provide motor speed adjustments to accommodatedifferent tissue thicknesses.

These features include a measurement device such as a force gauge, astrain gauge pressure sensor or other gauges/sensors to measure one ormore of i) the clamping force on tissue clamped between the instrumentjaws; ii) the clamping pressure on the tissue clamped between the jawsand/or iii) tissue density within the jaws of the instrument. Thegauges/sensors can be placed on various locations of the instrument,including proximal and distal portions. Alternatively, thesensors/gauges can be placed on the loadable power pack. Thesevariations are discussed in detail below with reference to FIGS.42A-45F. Note that the instruments of FIGS. 42A-44C show severalgauges/sensors within the instrument to illustrate examples of possiblelocations for the gauges/sensors. It is not intended that all of thedepicted gauges/sensors need to be in a single instrument as it iscontemplated that only one of the gauges/sensors is in the instrument.However, it is also contemplated that more than one gauge/sensor can beprovided in the instrument.

In some embodiments a screen is located in the handle housing (seescreen 613 of FIG. 42D) or on the power module to provide a visualindicator to the clinician of the measured parameter(s). For example,clamping forces, tissue or clamping pressures, and/or tissue densitiesmeasured or calculated by the sensors/gauges as disclosed herein can bedisplayed on the power module TTF, LCD or Human Machine Interface screento give real-time feedback to the surgeon. This real-time feedback canbe used along with tactile manual clamping. This can induce fasterlearning for the surgeon on acceptable tissue being clamped.

Turning first to FIGS. 42A-42F, several different possible locations forthe force measurement device are provided. For brevity of the drawings,as noted above, FIG. 42D and identical FIG. 43A show in a single drawingmultiple possible locations for the gauges/sensors. Note only one ofthese locations can be utilized or alternatively, gauges/sensors can beplaced on more than one of the identified locations, as well as in otherlocations. These locations can be on a movable part related to clampingof the jaws or on a joint where there is a transfer of force. As usedherein, the term measurement device will be used to denote gauges orsensors or other devices to measure one or more of clamping force,clamping pressure, tissue density and/or other parameter.

The instrument 600 of FIGS. 42A-43C is identical to the instrument ofFIG. 14A described above except for the measurement features and the campin/slot arrangement for opening and closing the jaws.

The cartridge jaw 607 is shown in the open position in FIGS. 42A, 42Band 42D, spaced from anvil (or anvil jaw) 605, i.e., the cartridgereceived in cartridge receiving channel of cartridge jaw 607 is spacedfrom anvil forming surface 605 a of anvil 605. The anvil forming surface605 a deforms the staples fired from the cartridge jaw 607. In the open(unclamped) position, the clamp pin 604 is at a distal end of clamp pinslot 603 (see FIG. 51 ). In this position, the clamp rod (clamp shaft)620 and the clamp laminates 616 are in the distal position. Clamplaminates 616 connect clamp rod 620 to the distal clamp adapter 622 viahook engagement of hook 616 a at the distal end of clamp laminates 616and a hook at the proximal end of the clamp adapter 622. The clamplaminates 616 can be fixedly attached to the clamp rod 620 and clampadapter 622 or alternatively floatably attached to these components. Theflexibility of the clamp laminates 616 allows for articulation of thejaws 605, 607.

Upon manual clamping of the handle 609, i.e. movement toward stationaryhandle 611, to effect closure of the cartridge jaw 607, the clamp rod620, which is operatively connected to the clamping handle 609, ispulled proximally, thereby pulling the attached clamp adapter 622proximally. This moves the through pin 604 which is attached to clampadapter 622, proximally within the cam slot 603 to move the cartridgejaw 607 toward the anvil jaw 605 to a clamped (closed) position as thecartridge jaw 607 pivots about pivot pin 624. The clamp pin 604translates in the slot 603 relative to the location of the clamp rodposition. The cartridge jaw 607 rotates around the pivot pin 624relative to the location of the clamp pin 604 in the cam slot. Thepin/slot arrangement is shown in FIGS. 49-51 . Further details of theclamp pin/slot structure for closing and opening the jaws are describedin application Ser. No. 16/792,110 and provisional application Ser. No.62/900,146, filed Sep. 13, 2019, the entire contents of which areincorporated herein by reference.

In the embodiments of FIGS. 42E and 42F, the measuring device is placeddistal of the handle housing 602. More specifically, in FIG. 42E. theload pin (clamp pin) 604, which is movable within the cam slot 603 asdescribed above based on the axial movement of the clamp rod 620,measures force as the cartridge jaw 607 is moved to the closed position.

In an alternate embodiment, the load cell 606 is located in the distalclamp adapter 610. The load cells herein can form transducers forconverting force into a measurable electrical signal. The distal clampadapter 610 is actuated, i.e., moved axially, by the clamp laminates 616which are connected to the clamp rod 620 which is movable to close andopen the cartridge jaw 607. Note the laminates have slots which interactwith the wall of the clamp rod 620 to move with the clamp rod, thus theyare floatably connected to the clamp shaft. The load cell 606 is shownlocated at a proximal portion of the clamp adapter 610 where it ishooked to the clamp laminates 616, however it could be located at otherregions of the clamp adapter 610. Axial movement of the clamp rod 620moves the clamp adapter 610 to measure force as the cartridge jaw 607 ismoved to the closed position.

In an alternate embodiment, the load cell 608 is located at a distal endof the clamp rod 620. It is shown at the distalmost end of the clamp rod620, where the clamp rod 620 is hooked to the clamp laminates 616, butalternately can be located at other regions of the clamp rod 620. Axialmovement of the clamp rod 620 measures force as the cartridge jaw 607 ismoved to the closed position.

Note these load cells 604, 606 and 608 are positioned at the distalregion of the instrument adjacent and proximal of the instrument jaws605, 607 and proximal of the jaw pivot pin 624. Note load cell 604provides an example of the measurement device on a load cell pin of theinstrument; load cells 606, 608 provide an example of the measurementdevice on an axially movable part tied into jaw movement placed underload during clamping of the jaws on tissue. In this manner, clampingpressure or clamping force can be measured. Tissue density can also bemeasured.

The measurement device can alternatively be positioned furtherproximally of the jaws 605, 607 as shown for example in FIG. 42F. Asshown, strain gauge 626 is located in the clamp shaft (clamp rod) 620distal of the handle seal. That is, it is adjacent the handle 602 anddistal thereof (and distal of the rotation knob 615). The clamp shaft620 is movable axially to effect jaw opening and closing and therebyenabling gauge 626 to measure the force. Alternatively, the strain gaugecan be located in a proximal region of the clamp shaft 620 proximal ofthe handle seal as shown for example in FIG. 43B discussed below.

In the foregoing embodiments, the measurement devices are positioneddistal of the handle housing 602. In the alternate embodiments of FIGS.43A-44C, the measurement devices are positioned in the handle portionwith FIG. 43B illustrating the measurement device within the handlehousing 602 and located in/on the axially movable clamp rod 620 andFIGS. 43C, 44B and 44C illustrating the measurement device on themanually actuated clamping handle or linkage.

More specifically, FIG. 43B illustrates strain gauge 630 positioned inthe proximal region of the axially movable clamp rod 620 within thehandle housing 602. Thus, the gauge 630 is positioned proximal of thehandle seal. FIG. 43C illustrates a) strain gauge 638 located at theproximal end of the proximal clamp adapter 632; and b) strain gauge 634located at the distal end of the clamp adapter 632. Proximal clampadapter 632 is actuated by the clamp pivot plate 640. Strain gauge 634is actuated by the proximal lip of the clamp rod 620 which is attachedto proximal clamp adapter 632. The clamp adapter 632, clamp rod 620 andclamp pivot plate 640 are shown in the enlarged view of FIGS. 46-48 .

In alternate embodiments, the load pin can be located at one or more ofthe pin locations on the clamp pivot plate 640. The pivot plate 640 isconnected at one end to link or clamp yoke 645 via pin 642 a and at theother end to clamp adapter 632 via pin 642 c. Link 645 is connected toclamping handle 609 at the opposing end. Pin 642 b, positioned betweenpins 642 a and 642 c connects to the adapter 632. Pins 642 a, 642 b, 642c form load pins for force measurement based on movement of the pivotplate during clamping of the jaws 607, 605 initiated by manual movementof handle 603. It should be appreciated that only one, only two or allthree load pins 642 a, 642 b and 642 c could be used in a singleinstrument. When clamping handle 609 is moved toward stationary handle611, it causes movement of yoke 645 which pivots the plate 640 clockwiseabout pivot pin 642 b to move the proximal clamp adapter 632 proximallyto effect proximal movement of the clamp rod 620 which moves the cam pin604 (FIG. 51 ) proximally within cam slot 603 to move cartridge jaw 607toward anvil jaw 605 to clamp the jaws.

In the embodiment of FIG. 44A, the load pin 646 is located at the clamppivot location, i.e., it connects handle 603 with the clamp yoke (link)645. Movement of handle 609 effects movement of clamp yoke 645 asdescribed above. In FIG. 44C, the load cell 648 is located in or on theclamp yoke 645 which can be in the form of a split yoke or completeyoke. It is outside the sterile portion of the handle housing 602 a andis positioned on yoke 645 between the handle 609 and the pivot plate640. The load cell can alternatively be positioned in other regions ofthe link 645.

As in the embodiments above, when provided on the instrument, themeasurement device, e.g., the force gauge/strain gauge can be in linewith the clamp linkage of the disposable instrument and/or in line withthe clamp rod. It can be in the front of the clamp stroke, in the middleor in the back at or near the proximal clamp adapter. It can be insideor outside the handle housing. It can also be offset from the clamp rodsuch as below or side by side with the clamp bar. It could also be inline in the tube, distal of the handle so it does not need to rotate. Itcan also be inside the distal jaws of the instrument.

As noted above, the load cell can in alternative embodiments be locatedin the removable power pack as shown in FIGS. 45A-45F. The forcegauge/strain gauge 654 is inside the reusable power module 652 andconnected to the clamp linkage of the disposable instrument eitherthrough a split clamp linkage or at end of the clamp linkage strokesupported with a spring. As described above, the power module 654 isloaded into the compartment of the handle housing 602 a and cover 656seals the compartment. The measurement device e.g., load cell 654,within power module 652 measures clamp linkage linear movement/distanceto determine the theoretical gap between the jaws for force measurement.That is, the load cell 654 mates with the clamp rod 620 as it drops intothe linkage and translates with the clamp rod 620 during axial movementof the clamp rod 620 to measure clamp force. This can be used togetherwith strain gauge/force gauge reading to calculate tissue densitythrough the entire clamp stroke.

The force gauge is powered from power module and communicates with thepower module microprocessor.

FIGS. 56-66B illustrate another alternate embodiment wherein the loadcell is positioned in the power pack. In this embodiment, the deploymentscrew 710 and articulation screw 750 are supported by axial bearings andthrust bearings.

Thrust (axial) bearings and radial bearings on opposing ends of thescrew 710 provide centering and axial alignment of the screw 710 duringuse. These thrust and radial bearings function in the same manner asthrust bearings 768, 780 and radial bearings 757, 782 of screw 754 ofthe embodiment of FIG. 59B of co-pending application Ser. No.16/792,110, filed May 15, 2020, the entire contents of which areincorporated by reference as noted above. As shown. thrust bearing 716is mounted at the distal end of screw 710 and thrust bearing 736 ismounted at the proximal end of the screw 710, proximal of collar 712, toresist any axial force applied to the rotating screw 710 and maintainits axial position. Radial bearings 724, 734 are provided to resistradial loads (forces that are perpendicular to the direction of thescrew) and are located on the respective distal and proximal ends of thescrew 710 with radial bearing 724 distal of thrust bearing 716 andradial bearing 734 proximal of thrust bearing 736. The thrust bearings716, 736 are slip fit over the outer diameter of the deployment screw710 (FIG. 59 ), at distal and proximal ends, respectively, and thusfloat relative to the screw 710. They are sandwiched together with thechassis. The radial bearings are press fit into openings in distal plate744 and proximal plates as in application Ser. No. 16/792,110. Thedeployment screw 710 has a reduced diameter portion at the proximal end(FIG. 57C) and distal end (FIG. 57B) to form a shoulder 713 and 715,respectively, at the larger diameter portions which abut, i.e., contact,thrust bearings 736, 716, respectively. Thus, the thrust bearings 716,736 can rotate freely within the housing, but are constrained by thesteps (shoulders) of the ball screw 710 so they cannot move along theaxis of the screw. The belt 723 and pulley 722 of the deployment(firing) mechanism are shown in FIG. 57B and are the same as in theforegoing embodiments.

Collar 712 has mounted thereto a pair of left and right track bearings714 which function in the same manner as left track bearings 779 and apair right track bearings 778, e.g., traveling along tracks in the 760,762, described in detail in the Ser. No. 16/792,110 application, therebypreventing rotation out of the track as forces are translated linearlyalong shaft as the nut translates forward and backward. The tracks canbe attached to or integrated (monolithic) with the chassis. The collar712, like collar 756 of FIG. 59A of the Ser. No. 16/792,110 applicationincludes a blade/tab extending inwardly from the wall which engages acircumferential recess (groove) in the deployment disk of the staplerwhich is attached to (or extends from) the firing rod of the stapler. Inthis manner, axial movement of collar 712 (via ball screw 710 whenactuated by the motor) moves the deployment disk axially, the collartraveling along the respective left and right tracks (runners) viarespective left and right bearings 714.

The deployment screw 710 includes a load cell or strain gauge 730 at theproximal end which is sandwiched between distal and proximal plates 738b, 738 a. The deployment screw 710 further includes a load cell orstrain gauge 720 at the distal end which is sandwiched between distaland proximal plates 718 b, 718 a. These load cells behind the thrustbearings measure force during firing. This can prevent the motor frombeing faulted. If the load cell detects an energy spike, a signal issent to the microprocessor within the power pack 700 to slow down themotor.

The articulation screw 750 has distal thrust and axial bearings 762,763(FIG. 62B) and proximal thrust and axial bearings 772,776 (FIG. 62C),similar to the thrust and axial bearings of the articulations screw 752of FIG. 60A of the Ser. No. 16/792,110 application. Articulation screwhas a load cell or strain gauge 760 (FIG. 62B) at the distal end whichis sandwiched between distal and proximal plates 764 b, 764 a. Thearticulation screw 750 further includes a load cell or strain gauge 770at the proximal end which is sandwiched between distal and proximalplates 774 a, 774 b. These load cells behind the thrust bearings measurearticulation force. This can prevent the motor from being faulted. Ifthe load cell detects an energy spike, a signal is sent to themicroprocessor within the power pack 700 to slow down the motor.

The present invention can also provide a system that indicates to theuser acceptable ranges for fastener application. Forces, tissue orclamping pressures, and/or tissue densities measured or calculated bythe sensors/gauges as disclosed herein can are displayed on the powermodule TTF, LCD or Human Machine Interface screen on the instrumenthousing to give real-time feedback to the surgeon. Based on forces,measured pressure and densities pre-calculated from tissue testing whichprovide a baseline and maximum and interim values, the Human MachineInterface (HMI) screen will indicate if the measurement is within anoptimal range for acceptable staple line outcome. This can be understoodwith reference to the diagram of FIG. 52 . FIG. 52 shows the gauges canbe provided a) in the clamp linkage (which includes components effectingmechanical clamping of the jaws (e.g., the manual clamp handle, campivot plate, adapter, clamp rod etc.) and/or b) in the power module,e.g., the component(s) therein tied into clamp rod movement; and/or c)in the instrument jaws. For (a) and (b) the clamp linkage movement,e.g., linear or pivotal movement is measured; for (c) the jaw movementtoward the opposing jaw is measured. This can provide sufficientinformation for force determination. However, the information can alsobe used to determine tissue density as depicted in the optional lastboxes of the diagram of FIG. 52 .

FIG. 54 provides a flow chart depicting one embodiment of a system wherethe instrument determines if the staple size is appropriate based on thepreset ranges where the values are pre-calculate/predetermined. Moreparticularly, the jaws are clamped on tissue in the manners discussedherein and a parameter, e.g., clamping force, pressure and/or tissuedensity is measured utilizing one or more of the measurement devicesdisclosed herein. The measured parameter is compared by themicroprocessor (e.g., a microprocessor in the power module) to thepre-set range. If the measured parameter is within the acceptable range,then firing is enabled and articulation is disabled. The microprocessor,based on the measured parameter, will then account for motor speedaccordingly. That is, the microprocessor will control and adjust themotor speed, i.e., the microprocessor using AI will control or changethe firing speed of the deployment motor based on the range detectedwhereas thin tissue will fire at faster speeds, medium tissue at nominalspeeds and thick tissue will fire at slower speeds to enable tissuefluid to egress and reduce the forces on the stapler system.

If the measured parameter is outside the acceptable range, then firingis disabled and the instrument recommends, e.g., via a screen or otherindicator on the instrument or power module, alternative size stapleload either smaller or larger in size.

Note the Human Machine Interface screen will indicate whether it is inthe acceptable range (thin/less dense/low pressure or medium/averagedensity/nominal pressure or thick/more dense/high pressure). It iscontemplated that in some systems, the optimal force/pressure/density oftissue would be staple load size agnostic and the same ranges wouldapply to all load sizes. In other systems, a staple size selector switchon the power module is provided so the forces/pressure/density would bestaple load size specific and in certain applications provide moreprecise indications/motor controls.

In some embodiments, if a strain gauge reading records a force/pressureor tissue density within a predetermined range so the stapling functionis indicated, i) the power module microprocessor will enable the firingsequence of the device to deploy staples and ii) the power modulemicroprocessor will disable the articulation functionality of thedevice. On the other hand, if a strain gauge reading records aforce/pressure or tissue density outside a predetermined range so thestapling function is not indicated, the power module microprocessor willdisable the firing sequence of the device putting it in a lockoutcondition not allowing staple firing.

In some embodiments, the surgeon will be provided the option to overridethe device.

A gauge in the form of a cartridge can be provided in some embodimentsso the surgeon can load and clamp on tissue prior to selecting acartridge load size. This cartridge load gauge enables the surgeon toselect a proper cartridge size without potentially wasting the wrongsize cartridge. The surgeon will load the gauge (dummy cartridge) intothe instrument. Then the surgeon palpates tissue with the jaws todetermine staple height size and the device will indicate an optimalcartridge size such as via an output on the screen. The surgeon thenremoves the dummy cartridge and inserts the indicated staple cartridgein the cartridge jaw. These steps are shown in the flow chart of FIG. 53.

A clamp indicator in the window/can be provided to show where in therange the tissue falls based on the cartridge selected. The firing speedvia AI (machine inference) can be controlled based on the cartridgeselected and/or clamp indication measurements.

In some embodiments, the power pack can have a reader, such as an RFIDreader, for detecting a type of staple cartridge prior to loading thestaple cartridge in the instrument. The staple cartridge can have a codeor tag, such as an RFID tag, and would be held adjacent the loaded powerpack for detection of the type of cartridge, i.e., the size of thestaples in the cartridge and/or the length of the arrays of stapleswithin the cartridge. When detected, a signal is sent to the controlmodule within the power pack to indicate which cartridge size isselected so the clamp force can be adjusted accordingly, and in someembodiments, indicated in the window/screen of the power module. Themicroprocessor can also preset the motor to correspond to the type ofcartridge selected. The control module can be configured so that if acartridge is loaded without its chip being read by the RFID reader, thenthe instrument cannot be actuated, e.g., cannot be fired. It can also beconfigured, so that the reader will detect if the cartridge has beenfired (spent), i.e., devoid of staples, and if spent, the instrumentcannot be actuated e.g., cannot be fired. The RFID tag can be on theplastic cartridge cover to minimize interference or assembled into thecartridge. Note alternatives to RFID readers to identify cartridge type,e.g., size, are also contemplated, with such identifiers communicatingwith the microprocessor in the power pack to adjust the clamping and/orfiring parameters.

The logic circuit in some embodiments could be as follows: 1) load thepower pack (in the home position) into the instrument compartment (theinstrument cannot be actuated unless a power pack is loaded); 2) closethe cover to enable the switch for articulation and the switch forfiring (an enable mode); 3) select a cartridge and hold it adjacent thepower pack to activate the load cells and to send a signal to themicroprocessor confirming the cartridge has not been previously firedand to set the firing speed and adjust for other parameters, e.g.,staple line length and firing stroke; 4) once all is active, place thecartridge in the instrument jaw; 5) the articulation switch and firingswitch can be activated for performing the surgical procedure.

In some embodiments, a supercapacitor on the PCB can be provided tostore enough energy to maintain microprocessor memory if the battery isexchanged or if the wrong size cartridge is utilized (wasted).

The load cell can be utilized in some embodiments for data acquisitionto provide post procedure evaluation. In the manual option, the sales/ORstaff will download case data from the power module via data transferinterface (e.g., USB). Data will be sent to HQ for trending andoptimization for future cases. The feedback can be used to providesurgeons with ideal load selection. Note this would require staffpresent to input outcomes. In an alternative automatic option, thesales/OR staff will connect to the device via Bluetooth/wireless ontheir iPad or other mobile device and the data will be sent from thesales staff iPad (or other device) for trending and optimization forfuture cases. Other data collected and stored for such uses can furtherinclude biometrics, number of devices fired by the power pack; thelength of the surgical procedures, forces generated, tissue information,operation of the stapling components and power pack components and otherparameters of the tissue, surgical procedure, stapling instrumentsand/or power pack.

The foregoing measurement devices were discussed for use in surgicalstaplers. They can be used in open and endoscopic and laparoscopicstaplers. However, they can also be used to measure pressure, forceand/or tissue density in other instruments with clampable jaws such asgraspers, energy devices, shears, clip appliers (where the measurementwould prompt the surgeon to check clip closure based on force feedbackof clip deployment).

Note the output can be digital. The output can be serial. It can bemeasured by voltage output.

A firing profile graph can be shown through HMI on the power module,visible through an instrument screen. High/low lines as with astatistical process control chart (SPC) will allow the surgeon tomaintain a “safe” firing speed. That is, the graph will provide anindication to the surgeons where they are during the stroke. Forexample, if force is too high, they may want to take action to reducethe force or pause firing. An example of a chart is provided in FIG. 83. In the chart, line A represents motor speed, line C represents themeasured force and line B represents the optimal force. As shown, forexample, if the force spikes, the motor speed is slowed accordingly.

In the foregoing embodiments, use of the power pack of the presentdisclosure to fire staples such as in endoscopic linear staplers, opensurgery linear staplers, circular staplers, as well as firing singleclips or tacks were disclosed as examples. It should be appreciated thatthe power packs of the present disclosure can also be used to powerfunctions of other surgical instruments. FIGS. 33A-34D illustrate twoexamples of such instruments.

In FIGS. 32A-32D an endoscopic scissors, designated generally byreference numeral 300, can receive and be powered by the power pack 18(or power pack 90) of the present disclosure. Scissors 300 has a handle306 manually pivotable towards stationary handle 304 to effect closingof the jaws, an elongated tubular portion 308 extending from the handlehousing 302, and a pair of pivotable jaws 312 with cutting edges.Closing of the jaws 312 severs tissue between the jaws. The scissors 300include a rotation knob 310 for rotation of the elongated portion(shaft) 308 to rotate the jaws 312. Power pack 18 is shown fully loaded(inserted) within the handle housing 302 and cover 303 is shown closedto seal the power pack 18 from the external environment. As in theembodiment of FIGS. 1-12 , the flag 42 extending from lead screw 36engages a rod within the handle housing 302 operably connected to a jawclosing mechanism to effect movement of jaws 312 toward each other tosever tissue between the jaws 312. Either one or both jaws 312 can bemovable.

In FIGS. 33A-33D an endoscopic grasper, designated generally byreference numeral 320, can receive and be powered by the power pack 18(or power pack 90) of the present disclosure. Grasper 320 has a handle326 manually pivotable towards stationary handle 324 to effect closingof the jaws 332, an elongated tubular portion 328 extending from thehandle housing 322, and a pair of pivotable jaws 332 with graspingsurfaces that can include teeth, roughened surfaces, ribs, etc. Closingof the jaws 332 grasps tissue between the grasping surfaces of jaws 332.Either one of the jaws can be movable, i.e., pivotable, or both jaws canbe movable (pivotable) toward and away from each other, for movementbetween closed and open positions. The graspers 320 includes a rotationknob 330 for rotation of the elongated portion (shaft) 328 to rotate thejaws 332. Power pack 18 is shown fully loaded (inserted) within thehandle housing 322 and cover 323 is shown closed to seal the power pack18 from the external environment. As in the embodiment of FIGS. 1-12 ,the flag 42 extending from lead screw 36 engages a rod within the handlehousing 322 operably connected to a jaw closing mechanism to effectmovement of jaws 332 to close the jaws to grasp tissue between the jaws332. It should be appreciated that the aforedescribed variations of thepower packs can also be used with the surgical instruments of FIGS. 32Aand 33A.

The power packs 18 and 90 disclosed herein can be used in surgery wherethe clinician manually clamps the jaws and actuates the motor or motorsto provide powered staple firing and/or powered jaw articulation. It isalso contemplated that the power packs 18 and 90 can be used withrobotic driven surgical staplers wherein clamping, motor actuation andany other functions of the instrument are performed robotically,including remote robotic control.

The staplers disclosed herein, or certain components thereof, can bemade of environmental friendly biodegradable materials. For example, thehandle can be made of biodegradable material. Such material can includefor example corn based lactic acid. The packaging for the surgicalstaplers and/or the packaging for the power packs and/or the batterypacks can also be composed of biodegradable materials to minimize thecarbon footprint.

Although the apparatus and methods of the subject disclosure have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentdisclosure as defined by the appended claims.

Additionally, persons skilled in the art will understand that theelements and features shown or described in connection with oneembodiment may be combined with those of another embodiment withoutdeparting from the scope of the present invention and will appreciatefurther features and advantages of the presently disclosed subjectmatter based on the description provided.

Throughout the present invention, terms such as “approximately,”“generally,” “substantially,” and the like should be understood to allowfor variations in any numerical range or concept with which they areassociated. For example, it is intended that the use of terms such as“approximately” and “generally” should be understood to encompassvariations on the order of 25%, or to allow for manufacturing tolerancesand/or deviations in design.

Although terms such as “first,” “second,” “third,” etc., may be usedherein to describe various operations, elements, components, regions,and/or sections, these operations, elements, components, regions, and/orsections should not be limited by the use of these terms in that theseterms are used to distinguish one operation, element, component, region,or section from another. Thus, unless expressly stated otherwise, afirst operation, element, component, region, or section could be termeda second operation, element, component, region, or section withoutdeparting from the scope of the present disclosure.

Each and every claim is incorporated as further disclosure into thespecification and represents embodiments of the present disclosure.Also, the phrases “at least one of A, B, and C” and “A and/or B and/orC” should each be interpreted to include only A, only B, only C, or anycombination of A, B, and C.

1-39. (canceled)
 40. A surgical fastener applier comprising: a housing;an elongated member extending distally of the housing and having alongitudinal axis; a first jaw and a second jaw, at least the first jawmovable with respect to the second jaw to a clamping position to clamptissue between the first and second jaws; a jaw clamping mechanism, theclamping mechanism including a clamping member movable to move at leastthe first jaw toward the second jaw to clamp the tissue between thefirst and second jaw; and a cartridge devoid of fasteners positioned inone of the first and second jaws, wherein a staple height size for afastener cartridge is determined by the cartridge positioned in one ofthe first and second jaws.
 41. The surgical fastener applier of claim40, wherein the fastener applier further comprises a motor poweredfiring mechanism positioned within the housing, the firing mechanismmovable between a first position and a second position, wherein movementto the second position effects firing of fasteners into the tissueclamped between the first and second jaws.
 42. The surgical fastenerapplier of claim 40, wherein the fastener applier comprises a motorpowered articulation mechanism positioned within the housing, thearticulation mechanism movable between a first position and a secondposition to move the first and second jaws to a position angled withrespect to the longitudinal axis of the elongated member, wherein thefirst and second jaws are articulable in a first direction with respectto the longitudinal axis and articulable in a second direction withrespect to the longitudinal axis.
 43. The surgical fastener applier ofclaim 41, wherein the fastener applier comprises a motor poweredarticulation mechanism positioned within the housing, the articulationmechanism movable between a first position and a second position to movethe first and second jaws to a position angled with respect to thelongitudinal axis of the elongated member, wherein the first and secondjaws are articulable in a first direction with respect to thelongitudinal axis and articulable in a second direction with respect tothe longitudinal axis.
 44. The surgical fastener applier of claim 40,wherein the cartridge devoid of fasteners is a dummy cartridge withoutany fasteners, the dummy cartridge loaded into one of the first andsecond jaws prior to firing of any fasteners.
 45. The surgical fastenerapplier of claim 40, wherein jaw clamping is manually actuated.
 46. Thesurgical fastener applier of claim 40, wherein proximal movement of theclamping member clamps the first and second jaws on tissue.
 47. Thesurgical fastener applier of claim 40, wherein a cartridge load isdetermined for indicating the fastener cartridge.
 48. A method ofdetermining cartridge size comprising: a) inserting into a patient afastener applier having a first cartridge devoid of fasteners, thefastener applier having a first jaw to receive the first cartridge and asecond jaw, at least one of the first jaw and second jaw is movable toclamp tissue between the first and second jaws; b) actuating a clampingmechanism of the fastener applier to clamp tissue between the first andsecond jaw to gauge tissue and provide an output of desired fastenerheight size; and c) removing the first cartridge and inserting into thefirst jaw a second cartridge containing a plurality of fastenerscorresponding to the desired fastener height size.
 49. The method ofclaim 48, wherein the cartridge devoid of fasteners is a dummy cartridgewithout any fasteners loaded into the first jaw prior to firing offasteners.
 50. The method of claim 48, wherein the output is provided ona screen of the fastener applier.
 51. The method of claim 48, wherein acartridge load is determined to gauge tissue.
 52. The method of claim48, further comprising the step of actuating via a motor a firingmechanism to fire the fasteners from the second cartridge into thetissue.
 53. A surgical fastener applier comprising: a housing containinga compartment, the compartment having a cover openable to provide accessto the compartment for removably loading therein a power pack having amotor; an elongated member extending distally from the housing; a firstjaw and a second jaw, at least the first jaw movable with respect to thesecond jaw to clamp tissue between the first and second jaws; and afastener firing mechanism positioned within the housing, the firingmechanism movable by the motor of the power pack loaded into thecompartment, the firing mechanism movable between a first position and asecond position to effect firing of fasteners into the tissue clampedbetween the first and second jaws; wherein the motor of the power packreceived in the compartment is not actuable unless the cover is closed.54. The surgical fastener applier of claim 53, wherein the coverincludes a member movable into contact with an activation switch in thepower pack when the cover is closed.
 55. The surgical fastener applierof claim 54, wherein the member comprises a projection extendingdownwardly from a proximal region of the cover.
 56. The surgicalfastener of claim 53, wherein the closed cover provides a compartmentsealed from external contaminants.
 57. The surgical fastener applier ofclaim 53, in combination with the power pack, the power pack includingan engagement member engageable with the fastener firing mechanism, anda switch in the power pack is actuable to actuate the motor to move theengagement member linearly to advance the fastener firing mechanismlinearly.
 58. The surgical fastener applier of claim 57, wherein thepower pack has a printed circuit board in communication with the switch.